This position will drive the SEC reporting function, manage all components of Sarbanes-Oxley compliance and assist with technical accounting matters facing a fully integrated, rapidly growing, publicly-traded biotech company. This is a highly visible role that will work closely with senior management. This position reports to the Associate Director, Finance and works closely with the Chief Accounting Officer and Corporate Controller.

Responsibilities: 

• Ensure that the Company’s public financial statements and other SEC filings are of the highest standards of quality, GAAP compliant and useful to management and the investing public
• Prepare and manage quarterly and annual process for filing Form 10-Q and 10-K (Edgar and XBRL), including drafting and reviewing documents, coordinating review by management, legal counsel and independent accountants while adhering to strict timelines 
• Work closely with investor relations to support the earnings call preparation, including the press release, script, slides and support thereof;
• Assist with the implementation of technical accounting pronouncements, including application of complex accounting matters such as revenue recognition, collaboration accounting, stock-based compensation and in/out-licensing transactions;
• Manage and coordinate SOX compliance efforts, including annual updates to flowcharts, narratives and control matrixes as well as review test plan and results;  
• Identify and recommend sustainable strategic and process improvements based on learnings from SOX compliance and assist company in prioritizing automated controls and processes over manual compliance;
• Support the external audit firm in their annual audit and quarterly review procedures;
• Assist legal with preparation of proxy statements and other periodic SEC filings; and 
• Special projects as necessary.

Requirements:

• 6+ years of relevant work experience showing progressive advancement; 
• CPA is required;
• 5+ years “Big 4” or large regional accounting firm experience in the life sciences industry preferred
• Individual must have strong teamwork, communication and analytical skills; and 
• Individual must have strong organizational skills and be able to work in a fast-paced dynamic team environment.
• Other:  High level of attention to detail. Aptitude for planning/managing deadlines. Exceptional communication skills, including the ability to effectively present information to various levels of an organization. Creative approach to problem solving. Ability to self-motivate and function independently. Strong commitment to a team approach and awareness of team and individual success dependencies

Freelance Graphic Designer Job Offer

JOB TITLE: Graphic Designer

LOCATION: Remote/ Woburn, MA

RATE: Project based. Depending on level of experience.

START DATE: ASAP

JOB TYPE: CONTRACT

COMPANY INTRO:  Abpro is a rapid growing  synthetic biology company located in Woburn/Cambridge, MA . The marketing team of Abpro is seeking for an experienced freelance graphic designer to join in the team!

JOB OVERVIEW:

1. Polish graphics and layouts for existing presentations/illustrations
2. Design customer-facing marketing communications including brochures, online ads, emails, print ads, flyers and tradeshow graphics.
3. Quickly customize marketing materials to suit the demands by marketing team.  
4. Some in – office training maybe required

MUST HAVES:

• 3+ years of professional graphic design experience
• Local (Greater Boston Area)
• Flexible working hours
• Knowledge of print and electronic file preparation
• Excellent graphical and typographic layout skills
• Excellent organizational skills and proven ability to deliver projects within assigned deadlines
• Excellent interpersonal skills and objectivity
• Able to work collaboratively in a team structure in a multicultural environment

PLUSES:

• You are a web designer

APPLY:

• If you are interested in this job, please email your resume, contact info with your portfolio to mwang@abpro-labs.com

           Address to: Ms. Wang

           Subject line : Graphic Designer

Position description:  

Payroll Associate is responsible for assisting with the accurate administration and accounting for Ironwood’s payroll. The ideal candidate for this role is a detail-oriented team player who learns quickly, communicates effectively, and feels motivated by a fast-paced environment. This position reports to the Payroll Manager. 

Responsibilities:

• Assisting and backing up the Payroll Manager in the following areas of responsibility:

           - Accurate and timely processing of bi-weekly payroll, recording all                  changes as necessary to maintain up-to-date payroll records                          - Reconciling ADP Quarterly Reports
           - Preparing data for SOX Audits
           - Responsible for tracking non-exempt overtime in SAP
           - Preparing monthly journal entries and account reconciliations
           - Prepare and submit 401K contributions to vendor
           - Maintaining payroll supporting documentation
           - Managing payroll tax activities in a multi-state environment,
              including compliance with federal, state and local regulations
           - Processing employment verifications
           - Updating ADP with tax rate changes
           - Troubleshoot employee issues as they relate to payroll or payroll                    related benefits
           - Generating ADP reports as needed

• Work closely with Human Resources and Equity on compensation-related issues
• Work with accounting group and assist with special projects

Requirements:

• Bachelor’s degree is a plus (preferably in Accounting or Finance) or equivalent
• Minimum three years of experience in payroll in corporate setting
• Experience with ADP payroll processing strongly preferred
• Excel proficiency (pivot tables, VLOOKUP function, manipulation of large data sets)
• Strong organizational skills; must be able to work in a fast-paced dynamic environment
• Willingness to learn new responsibilities
• Flexibility and team-oriented; ability to balance multiple priorities

Position description:

We are seeking a Brand Manager who has the skills, experience and passion to support the continued growth of LINZESS through the effective execution of Healthcare Professional promotion.  The candidate must be a proven strategic and analytic thinker who can effectively develop, manage, and implement impactful marketing programs and tactics. This individual will be responsible for development and management of the tactical elements of the brand plan, specifically focused the execution of sales rep delivered materials, field communications, promotional education programs, sales training, and tradeshows for LINZESS in conjunction with co-promote partner.  This position will report to the Product Promotions & Communications Leader. 

Responsibilities:

• Develop, gain approval, and launch the sales rep delivered promotional tactics in support of the Brand Plan and in alignment with co-promote partner;
• Execute the development of sales training materials, communications and strategically guide the development of new hire and POA meeting content in alignment with sales training and co-promote partner;
• Manage external vendor to support the successful execution of promotional speaker programs and ensure seamless integration with the field sales force;
• Manage external vendor in the production, distribution, and reporting of promotional materials and product samples;
• Execute the LINZESS tradeshow plan including national and local tradeshows;
• Support the Brand Director in development and management of LINZESS Brand and Tactical Plan 

Requirements:

• A minimum of 3+ years of pharmaceutical brand management experience; field sales, sales training or advertising agency experience a plus;
• Proven experience in designing innovative, best-in-class multi-channel marketing communications programs;
• A passion for creating and building brands;
• Strong project management skills;
• Ability to influence without organizational authority;
• Excellent written and verbal communication skills, in addition to excellent interpersonal and presentation skills;
• Ability to effectively work cross-functionally and with external partner(s);
• Ability to effectively work with external agency partners;
• Interest in working in an entrepreneurial culture.

Position description:

We are seeking a Senior Manager within New Product Planning who has the skills, experience and passion to represent the US commercial organization in shaping the product development path, by working as a member of cross-functional teams to align development plans with commercial strategy and optimize the overall market value of each pipeline asset. The Senior Manager will also be responsible for commercial assessments on business development opportunities, and establishing commercial strategies for future product acquisitions and/or licenses. 

The candidate must be a proven strategic and analytic thinker who can effectively work in a cross-functional team to efficiently prioritize key programs and move them forward.  This position will report to the Senior Director, New Product Planning, within the commercial organization.  

Responsibilities:

• Work closely with the Corporate Development team to prioritize opportunities for assessment based on potential value and strategic fit
• Deliver commercial assessments for external in-licensing opportunities that include commercial strategy, product forecast, commercial investment, and overall asset valuation in partnership with commercial analytics, corporate development, and finance
• Lead and guide discussions across the commercial organization to identify and refine commercialization strategies that will maximize value for target assets
• Work closely with R&D organization to align development plans with commercial strategy of pipeline compounds
• Lead and guide discussions on product strategies, identify and drive alignment on meaningful points of differentiation that will optimize overall commercial value of pipeline assets
• Create and maintain a target product profile and a commercialization plan for each pipeline product that is based on patient, physician and payer insights
• Deliver commercial assessments for pipeline programs, establish market entry strategies and build P&L components (revenue, field force, brand resources, price and discounts) for the assets for the US business 
• Establish for go/no go criteria for each stage of development and to provide input on portfolio decisions
• Stay abreast of key competitive development programs and changes in market dynamics; adapt program strategy accordingly to ensure profitability of emerging product lines. 

Requirements:

• Bachelor’s Degree (MBA or graduate degree in related discipline preferred);
• Minimum 4 years of direct experience in some combination of pharmaceutical commercial strategy, marketing, and/or business analytics;
• Experience developing market insights & using them to drive decisions & forecasts;
• Proven ability to work well in cross-functional teams, with strong collaborative skills;
• Independent self-starter with strong interpersonal skills including ability to communicate effectively and influence at all levels without authority;
• Exceptional analytical skills, strategic thinking, creativity and problem solving capabilities;
• Highly developed planning and prioritization skills;
• A passion for creating and building brands;
• Interest in working in an entrepreneurial culture.

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com .

KEY DUTIES:

• Coordinate with various functional areas in Clinical Development and Medical Affairs, Regulatory, and Project Management in planning and preparation of clinical and regulatory documents
• Act as Lead Medical Writer at Project level in planning & preparation of documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPs
• Take a lead role in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices
• Represent Medical Writing on clinical teams
• Plan and coordinate work with in-house Medical Writers and outside CROs to ensure quality deliverables within assigned time frames
• Mentor/supervise junior Medical Writers

TECHNICAL SKILLS: 

• Experience in clinical documents related to late phase studies
• NDA experience with active contribution in planning and preparation of summary documents is a plus

PERSONAL SKILLS:

• Excellent interpersonal and communication skills
• Flexibility/adaptability to work in a fast-paced and dynamic environment
• Proficient with MS Office and other related software programs
• Experience in managing people and projects
• Experience in working with cross-functional teams and engage/escalate to ensure quality deliverables in planned time frame 

MNIMUM EDUCATION AND EXPERIENCE:

• Advanced degree (MS or Ph.D.) in a relevant scientific field preferred
• 5+ years of industry experience as Medical Writer
• Experience in psychiatry/ neurology/cardiovascular/ analgesic therapeutic areas is a plus

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  Reporting to the Director of Strategic Sourcing (Clinical Development Operations), the successful candidate will be responsible for creating and tracking invoices against study budgets, managing purchase orders, and supporting the clinical contracts process.

About the role:

• Create and maintain study budgets documenting Clinical Development Operations projected spend across multiple protocols inclusive of vendor and investigational treatment costs (site costs)
• Track invoices against study budgets and escalate issues as required
• Resolve invoicing queries referencing budget and contracts
• Create and manage Purchase Orders, including reconciliation and retirement of out of date POs
• Manage centralized contract inventory and filing
• Coordinate regular contract meetings with key stakeholders (legal, finance and CDO business owner) and follow through to execution
• Contribute to the implementation of best practices and standards for clinical contracts and budget management, including sharing lessons learned. 

About you: 

Required:

• Expertise with MS Office and advanced Excel skills
• Expertise with spreadsheets and databases, prefer experience with Oracle Financial systems
• Must be comfortable working independently, and interacting with internal and external team members
• Strong verbal and written communication skills
• Excellent interpersonal and organizational skills
• Ability to deal with competing priorities
• Strong reasoning, detail orientation and problem solving abilities are essential
• Ability to work on teams and on multiple concurrent projects, and works well under general direction with tight timelines
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

Preferred:

• Bachelor’s degree with Business or Science focus
• At least a year of experience at a biotech/pharmaceutical company or contract research organization
• Basic understanding of clinical operations business analysis and financial fundamentals

Summary
Responsible for the design and execution of analytical method development experiments

Responsibilities and Tasks

• Generates, documents and supports method development and validation activities to meet regulatory requirements including preparation, data analysis and closure of method validation protocols
• Transfer of methods from Development to Quality Control (QC) and the transfer of methods between customer/contract labs and Pharmalucence
• Assists analytical investigations in support of Pharmalucence Development, Production, QC and contract customers
• Supports and documents analytical investigations and product impact assessments
• Compiles data from testing and inputs data into computer and/or development reports as required
• Trains and transfers analytical procedures to Pharmalucence QC
• Interacts with outside laboratories and contract customers
• Revises SOP’s as required
• Use of pH Meter, Analytical balance, Compressed Gas Cylinders, Fume Hoods, UV-VIS spectrophotometer, HPLC, IR spectrophotometer, Atomic Absorption spectrophotometer, KF Moisture analysis, and associated hardware and computer interfaces

Knowledge, Skills and Abilities

• Excellent verbal and written communications skills
• Excellent technical writing ability
• Attention to detail and regulatory compliance
• Solid knowledge of chemical and analytical principles and their practical applications
• Strong technical knowledge in analytical chemistry
• Method validation experience
• Ability to work under minimal supervision using standard and safe laboratory practices and procedures

Education and Experience

• BS in related scientific major required

Minimum 2-4 years related experience preferably in a pharmaceutical manufacturing environment

Pharmalucence is an Equal Opportunity Employer

Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you need help applying online, please contact joyce.robbins@sunpharma.com or call

Joyce, HR Assistant at 781-275-7120

The Associate Director (AD) will be responsible for managing, coaching, and leading a team of Contract / Alliance Managers located across Vertex’s global research organization (Boston, San Diego, and Milton Park, UK).  This team acts as the primary interface between the Research Scientists, Vertex Legal, and external 3rd party collaborators in supporting and enabling the legal contracting process to support external research activities and collaborations, as well as providing continued relationship management through the term of the collaboration in many situations. The team members all have scientific backgrounds, many with advanced degrees, which enable them to understand and integrate well within the Research community, and are well-versed in contract law.  The results-oriented AD will be responsible for the development of the team members and ensuring the team remains well-integrated into the Research organization.  Ultimately he/she will be responsible for overseeing all external research activities managed by the team and to continually monitor and drive the value delivered by the Team to Vertex.  

This individual will also be responsible for managing all associated processes/tools used by the Team, including contract management, Research-related regulatory compliance spend reporting, among others, to support the efficiency and effectiveness of the team.  A key success factor will be the ability to forge close relationships with Senior Management across the Research organization as well as with other functions such as Legal, Project Management, Compliance, and Finance.  

Minimum Requirements:

•  Minimum 10 years working in biotech/pharmaceutical company with focus on Research & Development collaborations 
•  Minimum 5 years Managerial experience, preferably in a Research-related, laboratory team who can demonstrate the ability to build, lead, and develop a strong team
•  College or University Bachelor of Science with preferred MS degree; advanced degrees (PhD, MBA) desirable
•  Strong technical background; proven ability to interface with Research organizations and scientists 

Preferred Qualifications:

•  Comfortable interfacing across all levels of an organization from bench scientists to Sr. Executives
•  Strong knowledge of contract law with a specific focus on Intellectual Property rights and ownership; comfortable interacting with Legal personnel.
•  Exceptional communication and presentation skills, both verbal and written.  Ability to listen and incorporate feedback into strategic
plans, vision, and direction yet leads with conviction and confidence.
•  Cross-Functional Collaborator able to establish strong relationships with external partners and internal stakeholders including Research scientists and the Legal team, among others.  
•  Process minded; past experience improving the efficiency of processes through rigorous application of tools and data analysis. 
•  Results driver who takes accountability and ownership; drives with a sense of urgency; proactive decision marker and problem solver. Comfortable working in a fast-paced environment, often supporting the team with short contract timeframes. 
•  Ability to travel to all Research sites approximately every quarter required. 

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.

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