We are seeking a highly motivated and energetic candidate (Principal Scientist) to lead Drug Product Process Development and Manufacturing for Momenta’s growing biosimilar and new drug pipeline.  The successful candidate will be  responsible for planning, coordinating, and managing the drug product process development / characterization activities, as well as oversight of contractors, CROs, CMOs for process development, characterization, optimization including associated  scale-up, technology transfer, manufacturing and validation activities.

The Principal Scientist of Drug Product Process Development will be responsible for working closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements and will conduct briefings and technical meetings for internal and external representatives including equivalent or above management.  This position will represent Momenta drug product process development and manufacturing to both internal and external organizations, including CMO/CROs and Momenta partners.

Requirements

• PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 6 years’ experience in a development environment.
• Demonstrated technical leadership skills
• Experience in drug substance and drug product process  development, characterization, transfer, and manufacturing.  Lyophilization is a plus
• Experience in cGMP, aseptic manufacturing of parenteral drug products.
• Experience in technology transfer and management of contract      manufacturers is a plus.
• Excellent communication skills including the ability to write technical reports and CMC sections for regulatory submissions
• Ability to work in a fast-paced, dynamic, environment.

Company Profile

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.  To receive additional information about Momenta, please visit the website at www.momentapharma.com.

Associate Director & Corporate Counsel, Commercial Law  

Reporting to the Senior Director and Assistant General Counsel, Commercial Law, this position will be responsible for providing guidance and legal support on commercial, healthcare and Canadian law issues.
 

Commercial Lawyer  

• Provide legal support to one or more internal clients in the commercial organization
• Provide legal support to Canadian commercial business, including Market Access and Government Relations
• Serve as legal representative on one or more cross-functional review committees for promotional communications, either at a brand level or across brands
• Support corporate compliance matters for US and Canadian business
• Provide legal review of non-promotional external communications materials, including reimbursement submissions
• Draft, review and negotiate   complex commercial contracts, including 3rd party vendor agreements, service agreements, consulting agreements, among others
• Supervise the work of paralegals in contract negotiation and legal research as needed
• Proactively prevent or minimize legal risk to the company, and help drive legal strategy to align with and achieve business strategic goals
• Serve as a business partner in support of key customer group(s) with minimal oversight and guidance from managing attorney
• Collaborate with IP, Medical Affairs, Compliance, Regulatory and other business groups to ensure robust and integrated client counseling
• Keep informed of new laws, regulations, and industry trends affecting the company, and assist with educating clients of changes in the legal and regulatory landscape
• Advise on fraud and abuse issues such as Anti-Kickback, False Claims, and compliance with OIG guidance
• Interact with and efficiently manage outside counsel

Minimum Qualifications

• Law degree from a nationally recognized law school and current admission to the bar
• Minimum of 6-8 years’ experience in legal practice (with a combination of large law firm and in-house experience strongly valued) 

Preferred Qualifications

• Strong preference to candidates with experience in the bio/pharma life sciences department of a leading national law firm and an in-house commercial legal practice at a biotech or pharmaceutical company  
• Strong working knowledge of laws, regulations, and industry guidance that affect the marketing of pharmaceutical products, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, state marketing compliance laws, and anti-bribery laws.
• Exceptional written, verbal and presentation communication skills
• Effective interpersonal skills and strong ability to communicate in both verbal and written form with employees throughout the company
• Excellent organizational and planning skills and the capacity to simultaneously handle a variety of complex matters
• Some travel to Canada required
• Language Requirements: Must be fluent in English. Proficiency in French or Spanish a plus

Quanterix is an exciting early-stage commercial company currently developing a transformational platform that combines proprietary single-molecule sensitivity, multiplexing and full automation with its revolutionary Single Molecule Array (Simoa) technology.  Located in Lexington, MA, the company has launched an instrument for the life sciences research industry.   With unprecedented sensitivity, precision, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications.   To support our solid growth, we are seeking a talented and highly motivated Head of Supply Chain to join our growing organization.  The successful candidate will have an opportunity to leverage his/her experience to significantly impact the growth and commercialization of an exciting new technology and be a part of a rapidly growing company.

Position Overview:

This position is responsible for all aspects of Supply Chain Management and Product Control for a Life Sciences manufacturing company with a highly complex technology, extensive product portfolio and a number of strategic collaborations.  Functional responsibility includes all aspects of purchasing and supplier management, production planning and scheduling, inventory control and spare parts management, receiving and global distribution and warehousing, including third-party warehousing.  The ideal candidate will be an innovative leader with a depth of experience in supply chain management as well as experience in Lean Manufacturing principles.

 Key Responsibilities:

Our Head of Supply Chain will be expected to:

• Implement a fully functional supply chain management and production control infrastructure, with P&L responsibility and accountability
• Develop, implement and achieve financial and supply chain performance metrics
• Develop supplier relationship management processes to negotiate pricing, contracts and supplier and quality agreements
• Develop supplier management processes to implement supplier audits, supplier scorecards and supplier correction action reporting
• Direct responsibility for a multi-million dollar annual budget
• Direct and implement Demand and Operations Planning, forecasting and master scheduling processes
• Direct and improve Receiving and Inventory control processes, including spare parts management
• Establish structured processes for transportation and brokerage management and rate negotiation
• Control maintenance and accuracy of data in ERP system
• Develop strategy for third party warehousing and distribution of hardware and spare parts
• Develop requirements and implement reliable supply chain for Europe and Asia
• Implement Lean Manufacturing concepts and techniques

 Qualifications:

The ideal candidate will have:

• Bachelor’s Degree in Business Management, Supply Chain / Operations Management or related field required.  MBA or Master’s Degree in Supply Chain preferred
• 10+ years of managerial experience in the logistics, purchasing, warehouse management or distribution
• Outstanding communication skills, developing and delivering impactful presentations
• Experience with GMP- or ISO-certified operations required
• CSCMP, APICS or Six Sigma Certification highly desired
• Experience with Lean Manufacturing and Continuous Improvement preferred
• Demonstrated creative critical thinker
• Excellent collaboration capabilities, with an ability to influence laterally and upwardly
• Demonstrated ability to work well within cross-functional teams as a team player
• Possess an ability to learn and master complicated concepts quickly and comfortably
• A strong work ethic, the ability to generate high quality data under tight deadlines, and a collaborative, proactive attitude

About Quanterix

Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts.  We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment.  We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation.  Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.

To apply, visit the Quanterix careers web site at: 

https://boards.greenhouse.io/quanterix/jobs/124518

Quanterix is an exciting early-stage commercial company currently developing a transformational platform that combines proprietary single-molecule sensitivity, multiplexing and full automation with its revolutionary Single Molecule Array (Simoa) technology.  Located in Lexington, MA, the company has launched an instrument for the life sciences research industry.   With unprecedented sensitivity, precision, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications.   Quanterix is looking to hire an experienced Senior Quality Assurance Specialist to join our growing team.  

This Senior Quality Assurance Specialist will be responsible for routine management and coordination of cGMP and ISO compliant systems and provide leadership for quality compliance activities and initiatives.

 Key Responsibilities:

• Perform product releases and associated batch record reviews
• Perform quality review of validation protocols and reports
• Active participant in audits performed by customers and regulatory agencies
• Manage Internal Audit Program
• Provide QA support of investigations, including nonconformance, CAPA, root cause analysis, complaints, out-of-specification and environmental excursion
• Maintain company compliance with national and international Quality System regulations for medical devices by evaluating current procedures and practices
• Participate in project teams and perform other related duties as assigned.

 Qualifications:

The ideal candidate will have:

• Bachelor’s degree in the life sciences
• 5 to 8 years of experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role
• Keen attention to detail skills

 Desired Experience, Knowledge, and Skills:

• Experience being the Quality Assurance project team representative on projects with tight timelines
• Demonstrated experience writing, reviewing and approving quality policies and standard operating procedures
• Ability to document, understand and resolve complex technical issues
• Ability to handle multiple priorities and meet established deadlines
• Excellent interpersonal and written/verbal communication skills

About Quanterix

Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation.  Our science and technology has been featured on CBS news, Good Morning America, The Boston Globe and several other prominent news sources.  For more information, visit us at www.quanterix.com

Quanterix is an exciting early-stage commercial company currently developing a transformational platform that combines proprietary single-molecule sensitivity, multiplexing and full automation with its revolutionary Single Molecule Array (Simoa) technology.  Located in Lexington, MA, the company has launched an instrument for the life sciences research industry.   With unprecedented sensitivity, precision, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications.   Quanterix is looking to hire an Engineer or Scientist  to join our growing System Integration, Test, and Validation team within the broader Engineering Organization.  

Responsibilities:

• Work with broadly cross-functional teams (and with external partners) beside other engineering disciplines to integrate, characterize, and test creative new diagnostic medical devices.
• Drive innovative integration of hardware, software, and chemistry into well characterized, robust, reliable systems.
• Act as a technical representative on development project teams.
• Design and execute experiments in a laboratory environment.
• Develop/document methods or procedures, execute them, and create reports for integration, characterization, and/or verification of engineering design improvements on existing systems and new products under development.

Skills and Experience Requirements:

• Bachelor's Degree or higher in one of the physical sciences or engineering disciplines. Master’s degree highly desirable.
• Experience with medical devices or analogous systems is required.
• Understanding of immunoassay, surface chemistry, and automated liquid handling is highly desirable.
• Systems Engineering and/or Integration experience is highly desirable.  Systems Thinking experience a strong plus.
• Must be willing to spend time working in a lab environment to build, test, or otherwise operate Quanterix systems.
• Strong statistical methods knowledge and experience.
• Excellent technical communication and writing skills.
• Collaborative spirit, positive attitude, strong work ethic.
• Domestic and international travel required (although it’s not frequent).

About Quanterix

Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation. Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.

Quanterix is looking to hire an organized, results-driven team player to join the Field Service organization as a Manager for Technical Support.  This role will be based in Lexington, MA leading the team which is the first point of contact for customer support technical questions regarding hardware, software, IT and assay related questions.  This position will report to the Director of Field Service.  Primary responsibilities for the successful candidate will be: to effectively coordinate the worldwide technical support queue and customer response; interact with customers on a daily basis answering technical questions and communicating the response to customer inquiries; provide support for engineers in the field requiring assistance; maintain and create service manuals and technical field instructions; and management of service part inventory.

Specific responsibilities include:

• To maintain customer response to technical support queue and maintain contractual response times. Lead coordination of technical support team members in order to ensure timely and thorough customer response.
• Provide real-time and follow-up support (software, technical, operational, electro-mechanical and logistical) to our customers, both internal and external.
• Partner with appropriate internal experts (manufacturing, engineering, R&D, sales, etc.) to author a plan of action to resolve customer issues quickly and effectively
• Log and track all support calls in the Technical Support database. Provide regular updates on key customer satisfaction metrics. 
• Coordinate with service parts buyer/planner to review safety stocking levels and on-time service part delivery levels, including supply tracking of part returns from field to manufacturer for repair.
• Coordinate and assign duties for writing Technical Service Bulletins, field service manuals and service part kit instructions. Review content with technical writers.
• Dispatch Field Service Engineers as required
• Report quality issues via corrective action process and coordinate response with Quality team.
• Document internal processes and continuously suggest improvements to current processes

This individual will be expected to:

• Provide calm, effective leadership to Technical Support Team solving immediate issues while instituting and modifying processes to prevent them in the future
• Provide customers with prompt, courteous, and effective service and support at all times
• Be an effective communicator – with stellar written and verbal communication skills
• Drive the appropriate resources to timely resolutions
• Be comfortable managing several deliverables at the same time, prioritizing and re-prioritizing as needed

Qualifications:

• Requires an AS degree or equivalent in the area of Electro-mechanical systems or prior military experience in this technical arena. BS in Engineering or Software Engineering preferred.
• 5+ years of successful experience in a Technical or Field Service role. Previous management or team lead experience preferred. 
• Demonstrated ability to communicate issues clearly within entire organization and solve problems independently.
• Ability to be persuasive while maintaining business relationships.
• Ability to work in a team environment and to meet deadlines is required.

 About Quanterix

Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts, USA with rapid global expansion – including this position supporting our European customer base. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation. Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.  For more information, visit us at www.quanterix.com. 

Quanterix is an exciting early-stage commercial Life Science company currently developing a transformational technology poised to unlock a world of insight into disease detection, diagnosis, and patient treatment.  Located in Lexington, MA, Quanterix is a leader in high definition diagnostics, delivering ultrasensitive single molecule measurement for the benefit of human health.  As our organization continues to grow, Quanterix has an immediate opening for a full-time Marketing Associate located in the Lexington, MA office. This position provides support and assistance to the sales and marketing team for the planning and execution of trade shows, management of scientific abstract and poster submissions and the opportunity to grow with a dynamic, exciting organization. The ideal candidate will have a passion for the Life Science industry and the versatility to wear multiple hats as needed.  Candidates should be able to manage varying responsibilities and interface with a wide variety of internal and external contacts.

General Responsibilities include:

• Plan and oversee all tradeshow logistics and preparation
• Manage scientific abstract and poster submissions
• Prepare and communicate pre-event and post-event follow up and promotions
• Maintain payments and budget tracking

• Manage the creation and ordering of collateral and booth giveaways
• Create promotional messaging for use in targeted e-blasts to customers
• Vendor relationship management, including necessary design work, printing, etc.

The ideal candidate will possess:

• Bachelor’s degree in marketing or related field
• 1-3 years of experience within a marketing role, preferably within the Life Science market.
• Very strong computer and general business skills
• Excellent organization, coordination, and communication skills required
• Experience with events/tradeshow management
• Experience with Salesforce.com, Hubspot, Joomla or similar platforms would be a plus
• Ability to adapt to rapid growth, evolving company needs and broad range of responsibilities
• Experience working closely with a remote sales team preferable
• Positive attitude and a sense of humor required

About Quanterix

Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation. Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.

Quanterix is an exciting early-stage company whose mission is to develop a game-changing platform that combines proprietary single-molecule sensitivity, multiplexing and full automation with its revolutionary Single Molecule Array (Simoa) technology.  Located in Lexington, MA, the company is launched a ground-breaking instrument for the life sciences and diagnostics industries.   With unprecedented sensitivity, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications. To continue our solid growth, we are seeking a talented and highly motivated Reagent Manufacturing Technician to join our growing organization.

Position Overview:

This position will be involved with all Reagent Manufacturing Operations for Simoa HD-1 assay components.  Responsibilities will include but not limited to protein conjugates, bottle/vial filling, buffer and diluent formulation.

Position requirements:

• S. in Chemistry, Biology or related Life Sciences
• 5+ years reagent manufacturing experience in the in-vitro diagnostic industry or similar industry with GMP/GLP experience
• Must have strong mathematical skills
• Experience with standard manufacturing processes and equipment (filtration, centrifugation, pipetting, HPLC, and antibody conjugation).

Additional Requirements:

• Lean manufacturing experience/certification
• You need excellent organizational, record keeping and verbal and written communication skills
• Demonstrated ability to work well within cross-functional teams as a team player
• Possess an ability to learn and master complicated concepts quickly and comfortably
• A strong work ethic, the ability to generate high quality data under tight deadlines, and a collaborative, proactive attitude.
• Inventory control and ERP experience.

You will be working in a fast-paced environment, on multiple projects, with some of the brightest minds in the business.  You will be a part of a rapidly growing company on a trajectory to have a major impact in the life science research and clinical diagnostics arenas.

Physical Demands

• Ability to lift assemblies 20-50lbs
• Ability to work in tight constricted areas

 About Quanterix

Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation. Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.

Quanterix is an exciting early stage company whose mission is to develop a game-changing platform that combines proprietary single-molecule sensitivity, multiplexing, and full automation. We are seeking a talented and highly motivated Technical Writer/Documentation Specialist to join our Quality Assurance team. If you have experience in preparing technical documents in compliance with Quality system guidelines, this could be a very rewarding position for you.

Responsibilities will include:

• Writing and editing technical documents to support the development and launch of the Immunoassay product line.  Documents will include equipment and reagent manufacturing procedures, test methods, operating instructions, test protocols and reports, SOPs, specifications, package inserts and product labels.
• Working closely with R&D and Manufacturing subject matter experts to understand the technical content and requirements of the documentation.
• Ensuring documentation is accurate, complete, meets specifications and adheres to standards for quality and style.
• Maintaining a high level of quality, clarity and consistency for all documents.
• Identifying areas of improvement in processes, styles and formats.
• Processing documents through the electronic documentation control system, maintaining revision control and managing reviewers on a tight schedule.

The position requires:

• Bachelor’s degree in Science, Medical Technology, English, or Technical Communications
• 2 years of professional experience in editing and/or writing for a technical audience.
• Experience working in a regulated environment (ISO, GLP, GMP) preferred.
• Excellent written and editorial skills.
• Ability to critically review own work before sending out for review.
• Demonstrated ability to work independently.
• Fluent in word processing; good working knowledge of software programs; experience with electronic document management systems is a plus.

In addition: You need excellent organizational and communication skills, a strong work ethic, the ability to generate high quality documentation under tight deadlines, and a superior attention to detail.  You will be working in a fast-paced environment, on multiple projects, with some of the brightest minds in the business. You will be a part of a rapidly growing company on a trajectory to have a major impact in the life science research and clinical diagnostics arenas.

• Identify, cultivate, and nurture relationships with key patient advocacy organizations, individual patient advocates, and other organizations focused on  patient education within key therapeutic areas; multiple myeloma
• Implement patient advocacy plan for multiple myeloma in the US aligned with Takeda business plan
• Ensures compliance with internal policies and external regulations in all program planning and execution
• Partner with Commercial, GMA, and Corporate Communication to develop and implement educational or awareness initiatives in the areas of multiple myeloma
• Serve as the internal liaison to commercial and GMA functions supporting the company’s branded products , VELCADE and NINLARO to provide patient insights and feedback
• Monitor outcome reports from approved company grants to patient groups, leveraging key learnings while assuring compliance
• Manage unbranded patient programs to include; mentorship,  Patient Ambassadors, L-POPs,  
• Serve as company representative with patient ambassador program, patient leadership council
• Identify opportunities and build company awareness and strategic relationships through participation in local advocacy events   
• Create standard operating procedures that increase departmental efficiency and cost savings

Qualifications

• BA/BS in communications, public policy, marketing or a related area.  
• Minimum of 6 years experience in a pharmaceutical/biotech company; patient advocacy, government relations, marketing, market access or in a patient, consumer or professional association
• In-depth understanding of healthcare, pharmaceutical and biotechnology industry required
• Solid understanding of relevant regulations and guidelines (eg, FDA, Pharma. Etc.)
• Demonstrated ability to lead cross-functionally to gain consensus and alignment
• Exceptional oral, written, interpersonal and presentation skills
• Solid ability to effectively influence and deliver information, and articulate advocacy position and/or issues to the leadership of the organization to gain alignment
• Solid ability to work independently with tight timelines
• Demonstrated track record of strong patient engagement; advocacy or other equivalent
• Solid business acumen; ability to direct and manage vendors to ensure successful implementation of initiatives
• Strong budget management competencies
• Consistently represents the company with the outmost level of professional to internal and external customers
• Experience with successful negotiation

• Minimal travel required;

• Assist Manager/Senior Manager/Director in leading financial plan and close cycles for income statement areas of responsibility.
• Lead financial planning and analysis support for assigned functions.
• Manage monthly financial close and variance analysis for assigned functions.

ACCOUNTABILITIES:

• Lead semi-annual financial planning processes for assigned functional teams, resulting in highly accurate submissions including cost center detail, management presentation book page summaries, and supporting analyses as required.
• Develop financial models and analytical tools to support function objectives and projects.
• Assist driving strategic decisions through NPV analysis, ROI modeling, and other financial metrics.
• Provide critical thought that may help drive strategic decisions and make recommendations to Senior Management.
• Serve as financial representative on key cross-functional teams and proactively provide advisory services.
• Drive the development and use of the financial planning system (Cognos, CentFunc) for assigned functions.
• Create, leverage, and deploy financial models for own use and those of other finance staff.
• Document models and processes and work to creatively and continuously improve the planning process.
• Manage the monthly financial close process including identifying and resolving discrepancies in actual transactions in SAP versus planned activity and instructing accounting to initiate correcting entries, as necessary, on an ongoing basis.
• Work with local and regional finance teams to develop detailed explanation for variances between actual and plan on a monthly basis for assigned functional areas.
• Design and distribute monthly reporting packages to senior management, summarizing functional area financial results.
• Design and implement solutions to streamline processes and create operational efficiencies.
• Educate functional management on the use of reporting tools and finance concepts.
• May include team leadership activities or oversight of Associate/Analyst activities.
• Additional duties and responsibilities as assigned.

Qualifications

EDUCATION, EXPERIENCE AND SKILLS:

• Bachelor’s degree required - Finance or Accounting preferred.
• Minimum of 5 years of business experience.
• Previous budgeting/planning/monthly variance analysis experience.
• Strong analytical skills with demonstrated business impact in previous position(s).
• Strong computer software skills (Microsoft Office Suite – Word, Excel, PowerPoint).

Desired:

• MBA or CPA.
• Previous experience in healthcare industry.
• Demonstrated business investment analysis modeling skills (NPV, ROI).
• Financial planning/reporting systems experience (e.g. SAP, Data Warehouse Programs, CentFunc, HFM).

SKILLS:

• Communication – Ability to communicate ideas and data both verbally and written, in a persuasive, organized and appropriate manner, including running meetings and preparing presentations for customer groups.
• Analytical – Ability to analyze monthly financial results and ROI outputs and to understand how to use this information to drive projects that will impact the business.
• Management – Ability to set priorities and meet specific deadlines in a changing environment, ability to be flexible, accommodating, and to deal with change effectively.
• Customer Service Orientation – Ability to gain trust of high-level management and leverage relationships to provide best possible financial plans and drive impactful analytical projects.
• Teamwork – Ability to work effectively in and foster a team environment, across multiple time zones.
• Entrepreneurial – Ability and desire to take ownership over activities and projects, desire to shape the organization, consistent demonstration of “out of the box” thinking.

TRAVEL REQUIREMENTS:

• Periodic overnight travel may be required.

we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

The Associate Director, Patient Advocacy R&D and Global, is a Global Oncology Business Unit position. It reports to the Senior Director, Patient Advocacy and is responsible for supporting Takeda’s commitment to:

• Ensuring the patient perspective is part of Takeda’s research and development strategies
• Development and execution of global patient advocacy relationships and initiatives

The Associate Director will partner with the R&D organization to integrate patient and caregiver insights into the drug development process.  The Associate Director, in collaboration with the Sr. Director, will, in partnership with OBU countries, implement a global-level strategic patient advocacy plan.  ACCOUNTABILITIES:   

• By working closely with Global Patient Advocacy leads within the respective LOCs, build, implement and sustain a global patient advocacy plan.
• Ensure a strong working knowledge of the global environment to identify opportunities to improve patient outcomes and identify solutions that educate and empower patient organizations to act to improve patient’s disease awareness, quality of life, and access to therapies.
• Manage the Global Patient Advocacy Council (GPAC) and establish best practices, guidelines, processes, metrics, methodology to provide education and training solutions to global Takeda stakeholders
• Serve as industry stakeholder on key committees (GMAN, Lymphoma Coalition)
• Deliver actionable patient and caregiver insights that inform discovery, clinical testing, delivery and the demonstration of value of company compounds and products
• Increase local operating companies’ advocacy skills through the support and expansion of a global internal network, GPAC
• Ensure the patient voice is integrated into Takeda Oncology’s global research and development policy and procedures across all brands and pipeline compounds  
• Deliver actionable patient and caregiver insights that inform discovery, clinical testing, delivery and the demonstration of value of company compounds and products
• Develop and align with key internal stakeholders including but not limited to medical affairs, marketing, market access, government relations, etc. 

Qualifications

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

• BA/BS in communications, public policy, marketing or a related area.
• Minimum of 6 years experience in a pharmaceutical/biotech company; patient advocacy, government relations, marketing, market access or in a patient, consumer or professional association
• In-depth understanding of healthcare, pharmaceutical and biotechnology industry required
• Solid understanding of relevant regulations and guidelines (eg, EMA, HTA)
• Demonstrated ability to lead cross-functionally to gain consensus and alignment
• Exceptional oral, written, interpersonal and presentation skills
• Solid ability to effectively influence and deliver information, and articulate advocacy position and/or issues to the leadership of the organization to gain alignment
• Solid ability to work independently with tight timelines
• Demonstrated track record of strong patient engagement; advocacy or other equivalent
• Solid business acumen; ability to direct and manage vendors to ensure successful implementation of initiatives
• Strong budget management competencies
• Consistently represents the company with the outmost level of professional to internal and external customers
• Experience with successful negotiation

  TRAVEL REQUIREMENTS:

• 20-30%

we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

The Manager of Medical Writing is responsible for the smooth functioning of all medical writing projects for clients and project teams through management of internal staff and the medical writing process. This role also maintains optimal department processes, implements project-specific strategies, and assists with the development and implementation of department strategies to increase productivity and quality. 

As the Manager, Medical Writing You Will...

• Assist with the oversight of medical writing personnel, including hiring personnel, managing personnel matters, and conducting performance evaluations for relevant staff.Be involved in training medical writing staff regarding applicable regulatory guidelines and medical writing practices.

• Serve as the lead Medical Writer on projects. As the lead Medical Writer, draft and finalize documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include, but are not limited to, clinical study reports, study protocols, investigator’s brochures, and manuscripts.

• Assist with resource allocation and with the development of business proposals related to Medical Writing functions. Work with Project Managers to develop timelines and resource plans for the production of clinical documents. 

• Review statistical analysis plans and case report forms as required. Perform “peer” and quality control (QC) review of clinical study reports and clinical sections of regulatory submissions written by other medical writers. Keep management informed on progress of documents and other project related information, assist management in projecting resources, and perform administrative duties as requested. 

Experience + Requirements

• Bachelor’s degree required.

• At least 10 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting. At least 5 years of line management experience.

• Some applied training relevant to the clinical trials or health research environment.

• Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research. 

The Manager, Statistical Programming is responsible for the statistical programming aspects of projects for clients and project teams through management of internal staff and for maintaining optimal department processes, implementing project-specific strategies, and assisting with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs.

Primary Duties + Responsibilities

• Assist with the oversight of SAS programming personnel, including hiring, managing personnel matters, and conducting performance evaluations for relevant staff. Train SAS programmers regarding applicable regulatory guidelines and programming activities. 

• Assist with resource allocation and with the development of business proposals related to Biostatistics and Programming.

• Serve as the programming lead on projects, as appropriate. As a project lead, the Manager, Statistical Programming develops and maintains a close liaison with client contacts, SAS programmers, biostatisticians, and project managers to drive the programmatic aspect of project delivery.

• Provide oversight of project-related statistical programming tasks, and performs project-related tasks, as required, including: communicating with Project Managers regarding resourcing to assure the appropriate staff is assigned to each study; providing input into Case Report Dorm (CRF) and Data Validation Specifications (DVS) development in all therapeutic areas; writing specifications for analysis files, consistency checks, tables, and figures; analyzing  clinical trial data producing accurate results representing the outcome of the trial; and validating statistical output.

• Provide input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.g., statistical methodology standards, standard data presentations).

• Participate in interactions with regulatory agencies, as required.

Experience + Requirements

• At least 6 years of biostatistics or SAS programming experience within the clinical trials or health research environment required. Master’s degree in Statistics, Biostatistics, or a related field, with applied statistics or SAS programming training relevant to the clinical trials or health research environment plus 3 years of biostatistical experience in the clinical trials or health research environment preferred.

• Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

• Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical and biotech companies.

POSTDOCTORAL SCIENTIST- PHARMACEUTICAL DEVELOPMENT (Protein)

JOB SUMMARY: We require a highly motivated Postdoctoral Scientist to work on protein stability & aggregation as it relates to therapeutic protein development. The current postdoctoral project is designed to understand the fundamental mechanism/s of protein instability, sub-visible particulate formation and aggregation using variety of chromatographic, biophysical and biochemical tools.

DUTIES AND RESPONSIBILITIES:

• Evaluate physical and biophysical properties of peptides, proteins, and bioconjugates relevant to drug development and subsequently communicate the interpretation and implication of results to clients.
• Develop analytical and high throughput biophysical methods to characterize product variants
• Execute and oversee specialized analytical testing and generation of technical documents
• Maintain a strong awareness of current scientific literature, particularly in the area of protein characterization, and actively apply new concepts as appropriate.
• Design experiments to develop pre-clinical and clinical formulations of drug candidates to support drug discovery and development.
• Design experiments to determine the stability in prototype clinical formulations, to detect and identify the decomposition products, and to achieve formulations with acceptable shelf-life.
• Perform laboratory experiments related to the above.
• Create presentations for outside scientific meetings and conferences to showcase Wolfe Laboratories’ scientific leadership in the field of protein analysis and characterization.
• Interface with clients to develop an in-depth understanding of client objectives and define solutions to meet their program requirements
• Develop compelling approaches and solutions to address client needs
• Write persuasive proposals for the projects
• Regularly interact with clients to keep them abreast of project progress
• Write and review interim and final reports

REQUIRED BACKGROUND AND EXPERIENCE:

• Ph.D. in Biochemistry, Biophysics, Chemistry, Biomolecular engineering, Organic Chemistry, Chemical engineering or closely related disciplines
• In depth experience in the area of protein biophysics involving structure-folding-stability relationships. This includes purification, stability, kinetics and thermodynamics of folding of monomeric proteins, particularly as they relate to the pre-formulation and formulation development of new drugs
• Hands-on experience with chromatographic method development as well as techniques used for biophysical characterization of biopharmaceutical products such as calorimetry, spectroscopy, higher order structure analysis, protein mass spectroscopy, CE, HPLC, ELISA, and carbohydrate analysis.
• Strong knowledge of Organic Chemistry principles
• A demonstrated drive to apply technical knowledge to developing drug formulations
• Established track record of significant contributions as an individual technical expert
• Outstanding written and oral communication  skills as well as polished and persuasive client presentation skills

ADDITIONAL DESIRABLE BACKGROUND:

• Good understanding of excipient and ligand interaction with proteins
• Evaluation of thermodynamic and kinetic models
• Experience in creating and delivering trainings

WHERE THIS JOB COULD LEAD:

At Wolfe Laboratories Inc., we pride ourselves on retaining and growing our team members, and ensuring they are developing to their full potential. This position can provide many different avenues for advancement, including 

• Training towards becoming a Project Manager
• Leader of an innovative business line
• Become a Lead Technical Researcher
• Managing a team of Postdoctoral employees

Interested candidates are requested to email a copy of their resume with a cover letter and unofficial transcripts to: steve.pangione@wolfelabs.com

Wolfe Laboratories, Inc. (WLI), located in Watertown, MA, is a premier contract research organization that provides integrated early drug development solutions to the biopharmaceutical industry.  Wolfe Laboratories is an essential element of the drug development ecosystem, recognized by global and virtual biopharmaceutical companies as a science-driven organization whose mission is to provide outstanding discovery and development services tailored to its clients’ needs for rational formulation development.  Wolfe Laboratories integrates the critical path components of early development to ensure that programs advance while meeting rigorous scientific demands with flexibility to address dynamic challenges and aggressive timelines.  Wolfe Laboratories’ vision is to improve human health, and we continue to strive towards that goal by embracing our core values of integrity, excellence and teamwork. The company has a high percentage of repeat clients, which is a testament to its long-term commitment of continual investment in its capabilities to meet biopharma’s growing demand for high quality, integrated early development services.

For more information visit us at: www.wolfelabs.com.

Wolfe Laboratories, Inc is an Equal Employment Opportunity Employer. 

JOB SUMMARY: We require a highly motivated scientist to work on protein stability & aggregation as it relates to therapeutic protein development. The successful applicant will be a key member of the team and will be responsible for understanding characteristics of candidate drugs and developing and executing the formulation approach that will be most successful. Furthermore, the successful candidate will define performance criteria for any products developed to ensure that clinical performance of manufactured product is acceptable. The company utilizes a wide range of in vitro (both biology and physical/analytical chemistry based), in situ, and in vivo techniques to achieve this goal. Creativity and innovation, built on sound technical knowledge and excellent problem-solving skills, are required in order to meet the challenges posed.

DUTIES AND RESPONSIBILITIES:

Scientific Responsibilities:

• Evaluate chemical, physical, and biophysical properties of peptides, proteins, and bioconjugates relevant to drug development and subsequently communicate the interpretation and implication of results to clients.
• Develop analytical and high throughput biophysical methods to characterize product variants.
• Execute and oversee specialized analytical testing and generation of technical documents.
• Maintain a strong awareness of current scientific literature, particularly in the area of protein characterization, and actively apply new concepts as appropriate.
• Develop and evaluate new cutting-edge technologies for protein product understanding, especially product heterogeneity and impact on safety and efficacy.
• Design experiments to develop pre-clinical and clinical formulations of drug candidates to support drug discovery and development.
• Design experiments to determine the stability in prototype clinical formulations, to detect and identify the decomposition products, and to achieve formulations with acceptable shelf-life.
• Perform laboratory experiments related to the above.
• Create presentations for outside scientific meetings and conferences to showcase Wolfe Laboratories’ scientific leadership in the field of protein analysis and characterization.
• Interface with clients to develop an in-depth understanding of client objectives and define solutions to meet their program requirements.
• Develop compelling approaches and solutions to address client needs.
• Write persuasive proposals for the projects.
• Regularly interact with clients to keep them abreast of project progress.
• Write and review interim and final reports.

Client Interaction Responsibilities:

REQUIRED BACKGROUND AND EXPERIENCE:

• Ph.D. in Biochemistry, Biophysics, Chemistry or closely related disciplines.
• Two or more years of experience in drug development from the post discovery phase to the initial clinical trials phase.
• In depth experience in the area of biophysical chemistry of proteins involving structure-folding-stability relationships. This includes purification, stability, kinetics and thermodynamics of folding of monomeric proteins, particularly as they relate to the pre-formulation and formulation development of new drugs.
• Hands-on experience with chromatographic method development as well as techniques used for biophysical characterization of biopharmaceutical products such as calorimetry, spectroscopy, higher order structure analysis, protein mass spectroscopy, CE, HPLC, ELISA, and carbohydrate analysis.
• A demonstrated drive to apply technical knowledge to developing drug formulations.
• Established track record of significant contributions as an individual technical expert.
• Outstanding written and oral communication skills as well as polished and persuasive client presentation skills.

ADDITIONAL DESIRABLE BACKGROUND:

• Good understanding of excipient and ligand interaction with proteins.
• Evaluation of thermodynamic and kinetic models.
• Postdoctoral experience in analytical biochemistry or closely related discipline.

Interested candidates are requested to email a copy of their resume with a cover letter, unofficial college transcripts, and salary requirements, to: steve.pangione@wolfelabs.com.

Wolfe Laboratories, Inc. (WLI), located in Watertown, MA, is a premier contract research organization that provides integrated early drug development solutions to the biopharmaceutical industry.  Wolfe Laboratories is an essential element of the drug development ecosystem, recognized by global and virtual biopharmaceutical companies as a science-driven organization whose mission is to provide outstanding discovery and development services tailored to its clients’ needs for rational formulation development.  Wolfe Laboratories integrates the critical path components of early development to ensure that programs advance while meeting rigorous scientific demands with flexibility to address dynamic challenges and aggressive timelines.  Wolfe Laboratories’ vision is to improve human health, and we continue to strive towards that goal by embracing our core values of integrity, excellence and teamwork. The company has a high percentage of repeat clients, which is a testament to its long-term commitment of continual investment in its capabilities to meet biopharma’s growing demand for high quality, integrated early development services.

For more information visit us at: www.wolfelabs.com.

Wolfe Laboratories, Inc. is an Equal Employment Opportunity employer.

The Senior Manager of Data Standards is responsible for leading and collaborating on projects dealing with the implementation of Standard Data Tabulation Model (SDTM) standards. 

As the Senior Manager of Data Standards You Will...

• Be responsible for oversight of all projects with SDTM component by creating project plans, monitoring project timelines, reporting on project status, identifying project resource needs and understanding contractual agreements to assure successful completion of project objectives

• Serve as an escalation point for sponsor contacts for resolution of project issues, timelines, and project strategy decisions

• Propose project strategies based on outcome of source data review, contract specifications and project timelines

• Provide expertise to Data Standards group in areas such as source data evaluation, authoring data conversion specifications, data conversion and pooling and publishing activities assuring adherence to regulatory standards

• Represent Veristat in multidisciplinary settings, assuring complete communication through participation, presenting and networking within the corporation and throughout the industry

• Be responsible for SDTM compliance and validation using current software accepted by the FDA (WebSDM, OpenCDISC)

• Identify potential process improvements that may increase productivity or quality of the data conversion

• Develop Standard Operating Procedures (SOPs) and standard documents relating to the implementation of SDTM

• Prepare and deliver SDTM presentations and training internally

• Manage staff growth and development through annual objective setting and performance review against goals

• Communicate team / individual goals and expectations to ensure direct reports understand their responsibilities

• Drive data standardization efforts within Data Management group

• Maintain status as a Registered Solutions Provide (RSP) on the CDISC website

Experience + Requirements

• Bachelor’s Degree in Computer Science, Statistics, or related field with a minimum of 8 years of SAS programming experience with clinical trial data and a minimum of 2 years of SDTM compliant implementation experience; Master’s Degree preferred

• Thorough working knowledge of CDISC SDTM Implementation Guidelines

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.   CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, save time, and provide consistent quality.              

We are seeking a talented and motivated R&D/Analytical Chemist to join our team.  This position will report to the Senior Director of Scientific Affairs. 

DUTIES & RESPONSIBLITIES

• Provide technical/scientific support associated with the Company’s NDA/505(b)(2) pathway pipeline programs as well as for the Company’s new FIRST kit development programs
  • With guidance, develops new robust quality formulations and analytical testing appropriate for current and new product lines
  • With guidance, reformulates and/or improves existing product formulas through research and analytical testing
  • Assists with authoring scientific papers and internal documentation such as development reports or comparative analyses vs. marketed products
  • Interface with external third party service providers (CROs and CMOs) while also effectively collaborating across various internal cross functional areas
  • Provide support for CMC section of regulatory fillings including but not limited to 505(b)(2) IND/NDA submissions
  • Ability to travel approximately 15% of the time.

ESSENTIAL REQUIREMENTS 

• Bachelors degree (or equivalent) in Chemistry or related field
• 3-5 years of experience in the pharmaceutical industry
• Strong knowledge of ICH guidelines, FDA cGMPs,  and USP-NF compendial methods such as HPLC, GC, UV, and IR.
• Excellent knowledge of pertinent SOPs and cGMPs related to compliance, regulations and guidances.
• Solid computer skills using Word, Excel, and Powerpoint
• Knowledge and application of good documentation practices
• The ability to organize, prioritize and deliver tasks and projects with a sense of urgency under minimal supervision without neglecting attention to detail
• Good interpersonal communication skills/ability to work in a team environment
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met.
• Excellent organizational, verbal and technical written communication skills.

 We recognize hard work and dedication with benefits offerings that address individual needs.  Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical and dental insurance
• Paid time off program, including paid vacation, sick and holidays
• Tax-advantaged 401(k) plan with employer match
• Company-paid life and disability insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, cover letter and salary requirements to careers@cutispharma.com

 NO PHONE CALLS PLEASE

 CutisPharma, Inc. is an Equal Opportunity Employer

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.   CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, save time, and provide consistent quality.              

We are seeking a talented and motivated Process Engineer to join our team.  This position will report to the Manager, Engineering.  In this newly created position, the Process Engineer works in the Engineering and Maintenance Department to provide technical support to Commercial Operations. Responsible for executing process development, implementation, maintenance and improvements for commercial GMP operations at CutisPharma’s manufacturing sites. This includes, but is not limited to, experimental support for deviations or manufacturing investigations, process troubleshooting, raw material evaluation, support of validation programs, exploration of process design space and continuous process improvement.

Key Responsibilities / Essential Functions

• Effectively identifies and addresses manufacturing challenges associated with manufacturing equipment performance and maintenance.
• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Identifies opportunity for improvements in reliability, repeatability and efficiency.  Effectively communicates and applies improvements with full compliance to OSHA, cGMP, and FDA regulations utilizing standard practices/ procedures for documenting changes and testing.
• Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Develop strategies for process validation activities. Writes and executes validation protocols and prepares data summaries for reports.
• Participates and or leads in fault-finding and route-cause analysis investigations as a subject matter expert. Effectively communicates findings to appropriate levels of the organization.
• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
• Sets priorities for Preventive maintenance and emergency equipment repairs.  Monitors and adjusts individual and team daily/weekly schedules to ensure business needs are met.
• Coordinates daily assignments including PM scheduling for self and other group members.
• Actively engage in safety and training initiatives, including but not limited to safety audits and inspections, ordering and distributing personal protective equipment (PPEs) and training materials, and participation on safety committee.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

Basic Qualifications

• BS in Mechanical/Electrical/Chemical Engineering and 3 years related experience in a pharmaceutical manufacturing environment.
• Good interpersonal communication skills/able to work in a team environment
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met.
• Excellent organizational, verbal, and technical written communication skills.
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs)
• Ability to operate a wide variety of test equipment, power and hand tools for the mechanical/electrical diagnosis, repair and/or fabrication of systems and components.
• Proficient in Excel, Word and Microsoft Outlook

Preferred Qualifications

• Specific detailed knowledge of all areas within product manufacturing process (e.g. pharmaceutical powder handling, packaging, component manufacture etc.)
• Additional requirements include advanced scientific analysis and problem solving work skills. An understanding of the application of lab scale testing to large scale processing, and an understanding of the Production environment, would be a plus.

We recognize hard work and dedication with benefits offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical and dental insurance
• Paid time off program, including paid vacation, sick and holidays
• Tax-advantaged 401(k) plan with employer match
• Company-paid life and disability insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, cover letter and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

CutisPharma, Inc. is seeking a detail oriented, dependable individual whose primary responsibility would entail supporting the Quality Assurance Unit.  The Document Control Specialist will be responsible for the design, implementation, and maintenance of the Quality Assurance Documentation and Change Control. Responsibility for issuance, tracking, and control of Standard Operating Procedures, Master Batch Records, Test Records, Forms, Protocols, Amendments, and Final Reports including formatting, editing, and revisions.

DUTIES & RESPONSIBLITIES

• Create and revise company standard operating procedures (SOPs) as required.

• Format, track and issue controlled cGMP documents including protocols, test records and forms.

• Assist in review of cGMP controlled documents as necessary

• Issuance of batch production records, tracking of master batch records, tracking of all batch production records and lot number issuance.

• Maintain validation files (validation protocols, validation summary reports, engineering change controls).

• Interface with other departments regarding documentation requirements.

• Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes.

• Provide back up and support to the Director, Quality Assurance

ESSENTIAL REQUIREMENTS 

• Bachelor's degree in science field.

• 2-5 years' experience in manufacturing cGMP environment performing Quality Documentation duties.

• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs).

• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met.

• Excellent organizational, verbal, and technical written communication skills.

Additionally, we prefer candidates that have:
• The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.

• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail

• The ability to enable and drive change while being focused on internal and external customers.

• Capable of managing multiple priorities.

• Proficient in Excel, word and Microsoft Outlook.

We recognize hard work and dedication with benefits offerings that address individual needs.  Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical and dental insurance
• Paid time off program, including paid vacation, sick and holidays
• Tax-advantaged 401(k) plan with employer match
• Company-paid life and disability insurance

Qualified candidates should submit their resume, cover letter and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

Make an impact at a dynamic and growing life sciences company. inviCRO seeks an accomplished scientist with experience in nuclear medicine physics and/or applications. The ideal candidate possesses graduate-level research experience as well as strong programming, image processing, and signal processing skills.

Overview:

This position is responsible for the development of analysis methodology, software tools, and algorithms for molecular imaging applications with a focus in nuclear medicine which may include, but is not limited to image registration, image segmentation, considerations in image reconstruction, technical support for DICOM and preclinical image formats, partial volume correction methods, tracer kinetic modeling, mechanistic modeling, general optimization techniques, and analyses of PET, SPECT, autoradiography, and gamma counter data. 

Responsibilities:

• Develop image analysis methodology from concept through to validation, documentation, appropriate SOPs, and application in close cooperation with our research-driven customers
• Translate image analysis tools and methods from prototype to deployment, including integration into established software platforms and dissemination to colleagues and customers successfully
• Manage customer-specific analysis projects, including generation of appropriate inviCRO-standard supplemental materials (QC, plots, reports, spreadsheets) in parallel with project-specific analysis output
• Oversee an image analysis team to achieve short-term and long-term image analysis goals 

Qualifications and Skills:

• PhD or Masters with 2 or more years of relevant experience in image science,      computer science, or electrical engineering with a nuclear medicine focus
• Knowledge of imaging modalities, primarily SPECT and PET with some experience with CT, and/or MRI and data formats, particularly DICOM
• C++, including ITK & VTK, Matlab, and JavaScript expertise required, Perl      preferred
• Strong analytical skills and ability to balance attention to detail while working to deadlines           
• Ability to multitask and work to deadlines in an environment of change
• Ability to learn quickly on the job through mentoring and action
• Self-motivated and resourceful with good interpersonal skills
• Ability to independently manage workflow to see projects through from start to completion
• Strong programming, image processing, and signal processing skills are critical requirements

To apply: Send cover letter and resume indicating your authorization status to work in the United States to jobs@invicro.com. Please note job title in the subject line of the email.

Additional information about inviCRO

inviCRO, LLC, was founded in 2008 with a mission to apply imaging technology and tools to address biological questions in drug discovery and development.  inviCRO provides state of the art contract research, advanced data analysis services and software for utilization in drug research. In collaboration with partner imaging centers, inviCRO offers full-service contract research in vivo imaging services utilizing SPECT, PET, MR, CT and optical imaging technologies, as well as ex vivo 2D and 3D autoradiography, fluorescence, and histology. Our multidisciplinary team of scientists develop unique imaging and bioinformatics tools that inform the design and analysis of imaging trials across many species and therapeutic areas. Our team brings together specialized knowledge in a broad range of disciplines, including advanced degrees in physics, optics, software engineering, electrical engineering, chemical engineering, mathematics, neuroscience, biomedical engineering and statistics.

We currently manage or support more than 250 pre-clinical and clinical imaging studies per year, processing more than 30,000 medical images per quarter. Our software products are helping scientists at more than half of the top 25 pharmaceutical companies. Visit www.invicro.com for more information.

Make an impact at a dynamic and growing life sciences company. inviCRO seeks an accomplished scientist with experience in image processing, particularly image registration and/or segmentation.  The ideal candidate possesses graduate-level research experience as well as strong programming, image processing, and signal processing skills.

Overview:

This position is responsible to develop methodology, software tools, and analysis algorithms for molecular imaging applications with a focus on image registration and segmentation for 3D data sets.  Molecular imaging applications span multiple imaging modalities (MR, CT, PET, SPECT, autoradiography, fluorescence, and histology) and disease areas (neuro, oncology, cardio, pulmonary). 

Responsibilities:

•  Develop image analysis methodology from concept through to validation and application in close cooperation with our research-driven customers.
• Create new tools and extend pre-existing tools for image registration and segmentation of 2D and, particularly, 3D medical image data.
• Transition image analysis tools and methods from prototype to deployment, including integration into established software platforms and dissemination to colleagues and customers successfully.
• Manage customer-specific analysis projects, including generation of appropriate inviCRO-standard supplemental materials (QC, plots, reports, spreadsheets) in parallel with project-specific analysis output.
• Oversee an image analysis team to achieve short-term and long-term image analysis goals.

Qualifications and Skills:

• PhD or Masters with 2 or more years of relevant experience in image science, computer science, or electrical engineering with an image processing focus, particularly for image registration and segmentation
• Knowledge of imaging modalities, primarily SPECT and PET with some experience with CT, and/or MRI and data formats, particularly DICOM
• C++, including ITK & VTK, Matlab, and JavaScript expertise required, Perl preferred
• Strong analytical skills and ability to balance attention to detail while working to deadlines           
• Ability to multitask and work to deadlines in an environment of change
• Ability to learn quickly on the job through mentoring and action
• Self-motivated and resourceful with good interpersonal skills
• Ability to independently manage workflow to see projects through from start to completion
• Strong programming, image processing, and signal processing skills are critical requirements

To apply: Send cover letter and resume indicating your authorization status to work in the United States to jobs@invicro.com. Please note job title in the subject line of the email.

Additional information about inviCRO

inviCRO, LLC, was founded in 2008 with a mission to apply imaging technology and tools to address biological questions in drug discovery and development.  inviCRO provides state of the art contract research, advanced data analysis services and software for utilization in drug research. In collaboration with partner imaging centers, inviCRO offers full-service contract research in vivo imaging services utilizing SPECT, PET, MR, CT and optical imaging technologies, as well as ex vivo 2D and 3D autoradiography, fluorescence, and histology. Our multidisciplinary team of scientists develop unique imaging and bioinformatics tools that inform the design and analysis of imaging trials across many species and therapeutic areas. Our team brings together specialized knowledge in a broad range of disciplines, including advanced degrees in physics, optics, software engineering, electrical engineering, chemical engineering, mathematics, neuroscience, biomedical engineering and statistics.

We currently manage or support more than 250 pre-clinical and clinical imaging studies per year, processing more than 30,000 medical images per quarter. Our software products are helping scientists at more than half of the top 25 pharmaceutical companies. Visit www.invicro.com for more information.

CutisPharma, located in Wilmington, MA, is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.  CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, saves time, and provides consistent quality.  The Company is searching for an experienced and enthusiastic, hands-on Vice President, R&D.

The successful individual will work cross-functionally, effectively collaborating across various areas including sales and marketing, research and development, quality, manufacturing and the executive team.

Dutis and Responsibilities:

• Lead, direct and plan overall strategy for developing and obtaining FDA approval of company’s 505(b)(2) clinical development programs
• Lead and oversee R&D activities of all other Company pharmaceutical products and projects
• Oversee the selection and management of CROs and bioanalytical laboratories supporting the Company’s development programs
• Lead the Company’s R&D team including external consultants supporting Company R&D activities
• Lead and oversee Company processes for creating and securing IP for technology generated by development activity
• Provide strategic input for the R&D pipeline to support existing and future products
• Establish and maintain relations with outside scientific and clinical experts in relevant disciplines to support the Company’s current and future planned R&D activities

Required Skills and Qualifications:

• MD or PhD in relevant disciplines pertaining to clinical development
• Minimum 10 years of experience in pharmaceutical development of clinical-stage programs, with at least 5 of those years in a senior supervisory role, including bioequivalence studies; prior experience in gastroenterology or infectious disease therapeutic areas preferred
• Robust clinical development experience with successful track record of programs leading to FDA approval; prior experience leading 505(b)(2) programs preferred
• Solid knowledge of FDA and cGMP regulations
• Solid knowledge and proven experience in creating and securing IP
• Strong leadership and management skills
• Excellent oral and written communication

We recognize hard work and dedication with benefit offerings that address individual needs.  Our comprehensive package of benefits for eligible employees includes:

 Competitive compensation package as well as bonus incentives for excellent performance

• Competitive medical and dental insurance
• Paid time-off and holidays
• Flexible Spending Accounts
• Tax-advantaged savings plans [401(k) with competitive company match and deferred savings plans]
• Company-paid life and disability insurance
• Free parking

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties to meet the ongoing needs of the organization.

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.    CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, saves time, and provides consistent quality.    The Company is currently experiencing significant growth in demand and seeks to bolster its commercial presence in the market by expanding our sales and marketing efforts. 

Reporting to CutisPharma’s VP, Sales & Marketing, the Manager, Sales/Marketing role is an exciting, dynamic position intended to encompass activities related to sales, marketing, and account management and provide a broad-based exposure across all key functions of CutisPharma’s commercial organization.  

Duties and Responsibilities:

• Product sales-   personal promotion to pharmacists via trade show attendance and direct contact with customers

• Assist Director, Trade Relations and Director, Managed Care in management of key customer accounts, including pharmacies/pharmacists, PBMs/Managed Care, Hospitals/GPOs, IDN’s wholesalers and distributors

• Development of marketing materials used for Company promotional efforts, including journal advertising, trade shows, electronic media and product launches.

• Flexibility to assist CutisPharma commercial team in other efforts, as required

Required Skills and Qualifications:

• High energy, dynamic personality who works well in a team-based environment and interested in a role that encompasses marketing as well as direct customer sales
• Pharmaceutical and/or other health-care related marketing/sales experience
• Familiarity with pharmaceutical industry and pharmacy environment including pricing, contracting, flow of money, understanding of industry trends
• Graphic design/layout experience-  familiarity with design software (e.g. Adobe Creative Suite)
• Ability and interest to travel (~20% of time)

Education/Experience:

• Bachelor’s degree required; preferably in field relevant to health-care related marketing; advanced degree (e.g. MBA, M.A., M.S., PharmD, or equivalent) preferred
• Minimum of 5 years work experience in health care, pharmaceutical or medical device industry

We recognize hard work and dedication with benefits offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical, dental and vision insurance
• Paid time-off program, Vacation
• Tax-advantaged savings plans [401(k) with match and deferred savings plans]
• Company-paid life insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market. CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, saves time, and provides consistent quality. The Company is expanding our sales and marketing efforts into the GPO and Managed Care Markets. 

Reporting to CutisPharma’s Marketing Manager, the Sr. Associate Contract Management role is an exciting, dynamic position intended to maintain GPO and DoD contract pricing and customer contracts.

Duties and Responsibilities:

• Execute Group Purchasing Organization and Federal Government related contract functions, including membership roster updates, contract pricing requests & administrative fee payments.

• Produce monthly and quarterly contract reports showing relevant business trends, including contract status, growth, expirations, opportunities and issues.

• Execute approved price file changes and contract amendments.

• Maintenance of manufacturer customer eligibility lists.

• Provide contract management support to Director, Trade Relations, Director, Managed Care, GPO and DoD  contacts, internal finance personnel, internal chargeback team and trade partners.

• Communicating with GPO partners, and trade partners to obtain/define contract eligibility.

• Completion of GPO member and trade partner audits and special reporting/projects as requested by specific GPO contract requirements.

.Required Skills and Qualifications:

• 3 – 5 years pharmaceutical contract administration experience with GPO’s and FSS/DoD.
• Experience with contract management systems a plus.
• Strong computer & M/S Office skills. Develops spreadsheets models for moderately complex financial analyses.
• Excellent verbal and written communication skills. Translates high volumes of data into meaningful information.

Education/Experience:

• Bachelor’s degree.
• Minimum of 3 - 5 years’ work experience in health care, pharmaceutical or medical device industry

We recognize hard work and dedication with benefits offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical, dental and vision insurance
• Paid time-off program, Vacation
• Tax-advantaged savings plans [401(k) with match and deferred savings plans]
• Company-paid life insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

DIRECTOR OF OPERATIONS

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.   CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, save time, and provide consistent quality.    We are seeking a talented and motivated Manager, Marketing Analytics to join our team.

In this hands-on position, the incumbent is responsible for managing the Manufacturing Operations team during the process of manufacturing products, performing scale-up and validation activities and preparing for commercial launch of drug products in an FDA regulated cGMP pharmaceutical manufacturing environment.

The incumbent is also responsible for assisting with or leading manufacturing capacity planning which includes expansion, design and build activities, procurement of equipment for current and future needs, oversight of plant commissioning and validation activities, hiring and development of staff, troubleshooting and optimization of processes.

Essential Duties:

• Organize, prioritize and execute manufacturing activities, including process and cleaning validation to prepare for commercial cGMP manufacturing.

• Implement, optimize, and troubleshoot manufacturing processes and equipment.

• Lead and coordinate the execution of protocols to support manufacturing process development and manufacturing equipment trials.

• Design and implement new manufacturing processes or changes to existing processes and oversee new equipment implementation or modification and validation.

• Write, execute, and review validation protocols for manufacturing/support equipment, processes and cleaning validation.

• Prioritize and guide resources in the design of new or improvements to existing manufacturing processes to deliver FDA compliant production capacity on time and within budget according to plan.

• Assist with managing capital plans for facility and production equipment related spending to assure production is in a position to meet new product development and product launch manufacturing requirements.

• Provide input to the specification and selection of manufacturing equipment and utilities.

• Lead projects such as; technology transfer, process design and optimization, scale-up activities, process and cleaning validations.

• Work with QA and compliance groups to validate drug product manufacturing processes for regulatory submissions, preparation for regulatory inspections and commercial production.

• Provide guidance and oversight of documentation systems for functional areas.

• Write, review and approve technical documents and reports such as protocols, batch records, SOPs, filing documentation and other cGMP documents.

• Develop and supervise direct reports.

• Independently champion manufacturing and validation projects.

• Identify continuous improvement and cost savings opportunities.

Candidate Attributes

• Exceptional organizational skills and attention to detail.

• Superior interpersonal and written communication skills and demonstrated ability to effectively communicate with all levels of the organization.

• Extensive knowledge of cGMP regulations and ICH guidelines.

• Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.

• Ability to clearly and concisely articulate constraints in a quantifiable manner and identify alternatives in order to keep projects on schedule.

• Ability to influence and negotiate skillfully through tough situations while maintaining good will and important relationships.

• Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.

• Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team.

• Ability to inspire transformative thinking and motivate employees to deliver benchmark performance.

• Ability to provide innovative, compliant ideas or alternatives that create value, including seeking new information and external insights.

Minimum Qualifications:

• BS in scientific related field, engineering or equivalent experience.

• 10 years of combined experience in pharmaceutical manufacturing, process development, and engineering or validation related functions.

• Hands on experience in validation, equipment troubleshooting and repair.

• Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs, Process validation, Cleaning validation.

• Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems, and pharmaceutical processing and plant equipment.

• Excellent technical writing, communication and organizational skills.

• Exceptional leadership and interpersonal skills and the ability to work well in a team environment.

We recognize hard work and dedication with benefits offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical, dental and vision insurance
• Paid time-off program, Vacation
• Tax-advantaged savings plans [401(k) with match and deferred savings plans]
• Company-paid life insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.   CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, save time, and provide consistent quality.              

We are seeking a talented and motivated QA Analytical Chemist to join our team.  This position will report to the Director of Quality Assurance. 

DUTIES & RESPONSIBLITIES

• Makes recommendations to Quality Assurance management for the disposition of product on Quality Assurance record review and approval.
• Works closely with contract manufacturers and contract laboratories and with other cross-functional impacted areas in a timely manner resulting from record reviews and deviation events.
• Reviews and assesses deviations; including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
• Reviews and approves Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
• Creates, reviews, and approves documents including Standard Operating Procedures, Technical Protocols and Reports, Annual Product Review, and other documents.
• Provides support for internal audits and regulatory inspections for cGMP compliance.
• Represents Quality Assurance to guide various projects and technical meetings, as needed.

ESSENTIAL REQUIREMENTS 

• Bachelors (or equivalent degree) in Chemistry or related field
• 3-5 years of quality assurance manufacturing experience in the pharmaceutical industry
• Strong knowledge of API’s: qualifying suppliers, USP analysis (HPLC, GC, and additional analytical analyses), etc.
• Excellent knowledge of pertinent SOPs, cGMPs, and related compliance regulations and guidances.
• Solid computer skills using Word, Excel, and Powerpoint
• Knowledge and application of good documentation practices
• Excellent verbal /writing skills
• Able to execute multiple tasks
• Good interpersonal communication skills/able to work in a team environment

•     Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs)

•     Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met.

•    Excellent organizational, verbal, and technical written communication skills.

ADDITIONAL PREFERENCES •   The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.

• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail

• The ability to enable and drive change while being focused on internal and external customers.

• Capable to manage multiple priorities.

• Proficient in Excel, word and Microsoft Outlook

We recognize hard work and dedication with benefits offerings that address individual needs. Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus  incentives for excellent performance
• Competitive medical and dental insurance
• Paid time off program, including paid vacation, sick and holidays
• Tax-advantaged 401(k) plan with employer match
• Company-paid life and disability insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, cover letter and salary requirements to careers@cutispharma.com

 NO PHONE CALLS PLEASE

 CutisPharma, Inc. is an Equal Opportunity Employer

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.   CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, save time, and provide consistent quality.    We are seeking a talented and motivated Quality Engineer to join our team.

The Quality Engineer will primarily be responsible for evaluating and assist in developing, as necessary, all quality characteristics of the plant facilities, validation and qualification activities, and equipment quality system (critical systems).  The Quality Engineer will execute and/or coordinate risk and gap assessment analysis to ensure that the plant critical systems and equipment are in a state of control.  The experience candidate will proactively participate in facilities and equipment quality system enhancement projects to decrease the likelihood of action(s) resulting from a regulatory inspection; and will work in partnership with manufacturing operations, research and development, engineering, maintenance and support areas to solve problems and provide expertise on compliance issues and corporate quality policy requirements relating to critical systems.

PRINCIPLE DUTIES AND RESPONSIBILITIES

• Evaluate facilities and equipment quality system.  Quality evaluation of the plant critical systems.
• Approve engineering change control for validated critical equipment and controlled areas which includes preapproving and approving of change controls.
• Provides quality oversight for process equipment qualification and commissioning, and facility commissioning and validation. Approves protocols/validations/qualifications.
• Analyzes data and assist in implementation of both corrective and preventative actions to enhance processes for critical systems and equipment (water, HVAC, powder filling equipment, capper, labeler, etc.).
• Leads and/or coordinates investigations related to critical systems and equipment. CAPA management and root cause analysis.
• Assist in gap analysis, FMEA and/or risk assessments to ensure evaluation of critical systems and equipment are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
• Interacts with the regulatory officials to convey the compliance level of the facilities and equipment quality system during regulatory inspections.
• Participates in quality projects and teams to implement improvements to the facilities and equipment quality system infrastructure to meet regulatory requirements.
• Provides training to appropriate personnel related to facilities and equipment quality system
• Trends and tracks critical system data as appropriate.
• Provides support to the plant during maintenance activities. 
• Perform other tasks on projects as needed/assigned.

QUALIFICATIONS

• B.S. Degree in engineering or technical science degree.
• Minimum 5 years QA experience in pharmaceutical or other highly regulated industry.
• Working knowledge of cGMP practices.
• Working knowledge of 21 CFR Part 210, 211 and USP, ISPE trends and guidelines.
• Must have experience in qualification and validation practices.
• Requires approximately 10% travel.
• Ability to work in a team environment.

We recognize hard work and dedication with benefit offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical, dental and vision insurance
• Paid time-off program, Vacation
• Tax-advantaged savings plans [401(k) with match and deferred savings plans]
• Company-paid life insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

CutisPharma, Inc. is an Equal Opportunity Employer

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.   CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, save time, and provide consistent quality.    We are seeking a talented and motivated Senior Compliance Officer to join our team.

The Senior Compliance Officer will support the pharmaceutical manufacturing programs at CutisPharma, as well as Quality for contract manufacturing programs, as necessary.  The Senior Compliance Officer is responsible for developing and ensuring site execution of quality strategies that ensure pharmaceutical product manufactured at CutisPharma are produced in compliance with applicable regulations and corporate quality expectations, and are released in a timely manner to meet production and supply timelines.  The successful candidate will support pharmaceutical manufacturing and the corporate supply chain (manufacturing, packaging, testing and distribution).  The Senior Compliance Officer will develop strategic direction and ensure execution of continuous improvement through idea development, plan creation, implementation, and interaction with team leaders in Operations, Production, Research and Development and Warehousing.  The Senior Compliance Officer will collaborate with the Director, Quality Assurance to ensure the development, implementation and maintenance of GMP quality operations.

PRINCIPLE DUTIES AND RESPONSIBILITIES

• Develop and lead quality operations strategy specific to providing supply chain products that ensure CutisPharma;s quality expectations, minimizes compliance risk, and assures current Good Manufacturing Practice (cGMP) compliance.  Lead internal staff and outsourced personnel/vendors in execution of strategy and identify continuous improvement plans and opportunities.
• Oversee daily GMP quality operations and timely disposition of pharmaceutical manufacturing to support CutisPharma’s supply chain demands, while assuring product quality and compliance.  Develop solutions to complex issues and Quality initiatives with Production and Warehouse team leaders, following cGMP regulations and CutisPharma standards
• Organize and develop timely action plans in close coordination with area leadership, ensuring a seamless execution of successful QA strategies.  Advance GMP QA’s ability to provide support to internal stakeholder strategies based on a thorough understanding of and alignment with key business drivers and company strategy.
• Have strong knowledge and understanding of the broad CutisPharma supply chain.  Identify, understand, analyze, and identify risks and quality issues, and develop mitigation strategies.
• Provide site leadership to ensure timely, well-documented, and compliant resolution of quality issues and implementation of corrective actions that maintain a continual state of regulatory compliance for pharmaceutical manufacturing and development activities.
• Ability to work in a team environment.

QUALIFICATIONS

• Bachelor’s Degree in chemistry, engineering or related field.  Minimum of 10 years pharmaceutical manufacturing and packaging experience including at least 5-7 years in GMP QA/QC/compliance.

• At least 5-7 years of managerial experience in a similar setting.
• Experience in quality assurance of drug product through the lifecycle of pharmaceutical product development.
• Track record of successfully working with and managing third-party vendors.
• Experience applying GMP Quality knowledge through standard operating procedures (SOPs) to facilitate business operations and in some cases, develop procedural solutions to appropriately resolve quality and compliance challenges.
• Experience applying Quality Systems (e.g., change control, deviations, CAPA, complaint management, and documentation management among others).
• Proven experience in leading Pharmaceutical Quality support.
• Experience in production management, specifically in cGMP manufacturing and packaging, highly desirable.
• Experience in equipment commissioning, qualification, process validation and Quality by Design (QbD) experience a plus.
• Experience in corporate integration activities, a plus.
• Requires approximately 10% travel, both domestic and international.

 ADDITIONAL SKILLS

• Superior reasoning and problem solving skills with the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
• Excellent interpersonal, communication and writing skills.
• Ability to effectively present information and respond to questions from Senior Leadership, peers, and external personnel.
• Adept at identifying prospective problem areas and recommending process improvements.
• Ability to manage multiple tasks, meet deadlines, and work under pressure in a fast paced environment. 
• High level of integrity and dependability with a strong sense of urgency and results-orientation.
• Fundamental understanding of pharmaceutical manufacturing and the drug development process, scientific methods and thought.

We recognize hard work and dedication with benefits offerings that address individual needs.
Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus incentives for excellent performance
• Competitive medical, dental and vision insurance
• Paid vacation, sick, holidays and floating holidays
• 401(k) with Company match
• Company-paid life/AD&D and disability insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

NO PHONE CALLS PLEASE

Mission Statement

Symbiota is pioneering microbial solutions for Agriculture. By unlocking the beneficial microbes that naturally live within healthy plants, Symbiota is developing breakthrough products that harmoniously work with plants to naturally promote crop health and performance.  Symbiota has built the first platform for microbiome product discovery in globally important crops, including corn, soy, wheat, cotton, and vegetables. Product Development plays a cornerstone role in advancement of outcomes from our discovery program towards commercialization and enhancing our understanding of performance interactions and drivers.

Symbiota is currently expanding its field trialing and product development capabilities to support development and advancement of our product leads and to enable the development of data/knowledge assets that enable optimization of our efforts spanning discovery, development, commercialization and product use.

Role Purpose: The purpose of the Director of Field Trialing is to lead the planning and implementation of Symbiota field trialing efforts in support of agreed business needs and priorities.  Measures of success include the efficiency of trialing planning/operations, quality of trial outcomes, compliance with policies/regulations and the recruitment, management and development of internal and external team members.

Outcomes

• Symbiota has a fully developed and functioning network of field trial cooperators who deliver high quality field trial results the meet our business needs (on time, on budget, high quality, target environment, well annotated environment/trials, etc.) 
• Field trial planning and implementation process enables the timely and effective engagement of resources and the monitoring of progress at appropriate milestones for effective trial completion (space planning, entry nomination, trial design, protocol definition/communication, materials planning, cooperator contracting, cooperator training, trial/cooperator monitoring, data collection and analysis). 
• In field observations linked to well conducted, annotated and analyzed trials lead to insightful and actionable results presented in a way that which enables Symbiota business decisions relative to advancement, placement, management and development of our microbial products. 
• Continual evolution of field trialing methodologies in service of improved quality, efficiency and knowledge content from our trialing efforts. 
• A motivated, capable and high quality staff and contractor network capable of reliable delivery of field trial outcomes. 
• The creation of a “data asset” that supports current trial objectives and establishes a high value data resource that creates optimal value for broader needs spanning discovery, development and commercialization needs.

Responsibilities for the Director of Field Trialing

• Design and oversee ongoing implementation of the Symbiota field trialing efforts that support the business needs/objectives.  Provide innovative and creative field validation solutions to confirm plant-microbe interactions. 

• Establish field trialing support infrastructure capable of overseeing and optimizing the results from Symbiota field trialing effort 

• Recruit, hire, train and manage 3-5 direct reports and additional seasonal staff 

• Establish and maintain a field trialing network consisting of collaborators and contract service providers capable of delivering on Symbiota field trial needs 

• Continuous improvement of direct reports and contractors through performance management, training, mentoring and development initiatives 

• Drive the implementation of trial meta-data collection and environmental characterization to optimize biological insight and long term value of trial data and observations 

• Work with Symbiota colleagues to plan and track trial demands and facilitate timely and effective trial planning and design 

• Ensure that field trial plans align with needs for effective stage gate advancement of candidates in the product pipeline 

• Define and communicate trialing protocols and standards to Symbiota trialing cooperators 

• Design and implement trial cooperator training and milestone tracking process 

• Ensure timely data collection, data quality control/release and the routine analysis of trials 

• Contribute to and/or lead in depth analysis and interpretation of field trial results 

• Operation of an efficient and reliable trialing platform that meets our evolving field trial needs. 

• A reliable, efficient and predictable field trial process that spans trial planning, trial implementation, data collection, data quality control and routine trial analysis. 

• In depth observation, knowledge and characterization of trials that enables deep insight into trial quality, plant performance and the environmental context relating to the trial outcomes. 

Competencies

• Planning, conducting, analyzing and interpreting agricultural research field trial data. 

• Central objective of team success, shared goals, and bridge-building across departments, partner companies, and customers.  

• Demonstrated strength in development and management of a strong team. 

• Strong organizational and communication skills. 

• Proven ability to establish and maintain strong internal and external collaborative relationships. 

• Proficiency in use of one or more field research trial planning, data management and analysis platform. 

• A highly goal-focused and schedule-focused approach to work. 

• Successful track record in managing substantial projects with complex interdependencies. 

• Outstanding leadership, motivational, interpersonal, and communication skills. 

• Passion for working in an extremely dynamic, execution-focused, entrepreneurial, small company atmosphere. 

Background, critical knowledge and job requirements

• A graduate degree (PhD or MS) in agronomy, plant breeding or related area and a minimum of 5 years’ experience running a field research program 

• Extensive experience with the analysis and interpretation of field trial data 

• Demonstrated competency in statistical analysis methods and interpretation 

• Proven capability managing employees, external collaboration and internal stakeholder relationships 

• Strong commitment to ethical and legal compliance 

•  Ability to travel up to 35% of the time (mostly domestic with some international travel required) 

• Ability to use MS Office programs and/or other standardized computer tool platforms 

• Ability to learn and use proprietary systems for data management, reporting and other job related functions 

• Ability to work under typical field research conditions
• A valid driver’s license
• email resumes to:    dirfieldtrial@symbiota.com