Sr. Research Associate  will join a team working on discovering novel small molecule therapeutics in oncology.

For details visit:

http://www.cwsciences.com/Current-Openings/Sr-Research-Associate--Oncology

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com

We are looking for a mechanically skilled candidate to support laboratory expansion. You will be part of the Lab Operations team supporting the relocation of laboratory inventory to two new locations in Cambridge.

For details visit:  http://www.cwsciences.com/Current-Openings/Laboratory-Operations-Coordinator

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com

Primary responsibility will be to coordinate follow up to customer inquiries that require consultation from the medical affairs team. Working within a small team, the ideal candidate will be the centerpiece to ensure that customer (physician) requests are arranged, prioritized and completed in a timely manner. This position requires availability off-hours and on weekends and the successful candidate will be expected to be available and respond to inquiries with reasonable urgency.

• Assist in the logistics and coordination of staff to support “on call” responsibilities, including External MD consultant responses to customer inquiries and SMART Clinical Trials, and other collaborative efforts, as needed.
• Key daily activities will include management of consultant schedules to facilitate timely client follow-up, in accordance with FMI Medical Affairs turnaround time (TAT) metrics, compiling required patient documentation to facilitate the interaction and recording the response/follow-up, as needed.
• Facilitate submission of compensation invoices and/or expense reports for consultants and other individuals supporting Medical Affairs programs.
• Assist with compilation and submission of Medicare appeal package in support of the Medicare patient testing reimbursement program.
• Perform administrative tasks to ensure the successful operation of the Medical Affairs team (business travel/meeting/interview scheduling, on-call schedule, team calendar maintenance, etc.) and other duties, as assigned.
• Handling and organizing confidential and highly sensitive information with the utmost integrity and with patients' best interest in mind.

• Bachelor's degree – a scientific discipline preferred, but not necessary. Prior experience (≥3 years) in healthcare administration or biotech/pharmaceutical company.
• Proficient in using office software/office management products, such as Microsoft Office (Word, Outlook, PowerPoint, Excel, Concur, CRMs - SalesForce.com, Microsoft Dynamics, etc.).
• Exceptional physician relationship building skills required; experienced and efficient in managing physician schedules/physician follow-up within busy physician practices.
• Exceptional written and verbal communication skills, including the ability to clearly communicate business processes and solutions in person and over the phone.
• Exceptional organizational and time management skills, including the ability to multi-task and work independently as well as part of a team.

• Ability to effectively manage all activities associated with key Medical Affairs initiatives to facilitate execution of team deliverables
• Ability to multitask
• Ability to write executive call summaries and document follow up steps
• Ability to work in fast paced environment

• Education- B.A. or BS
• Experience- ≥3 years in healthcare administration
• Experience- working with cross- functional teams and task forces
• Experience working with physicians in the past is preferred

Apply Here

PI92729780

This Director level position will function as Program Manager for companion diagnostic development (CDx). The Scientific Program Manager will direct the execution of multiple cross-functional work streams at Foundation Medicine leading to the development, approval, and marketing of FDA-regulated diagnostic products. Using sound Project and Portfolio Management principles, the Program Manager will manage resources, scope, tasks, scheduling, stakeholders, and risks on multiple projects. Additionally, the Program Manager will use their scientific expertise, evaluate and document existing assay systems, leading development of detailed specifications for new systems, and recommending optimization protocols. The position will require close collaboration with various stakeholders including business owners, senior management, external partners, vendors, and software engineering and laboratory staff.

• Lead and manage cross-functional project teams from project inception to product launch, including defining product requirements, design and implementation of technical workflows, and performance of validation and verification activities
• Lead development of product documentation in fulfillment of QSR design control, including CDx assay requirements, functional specifications, use cases, sequence diagrams, flow charts, etc.
• Direct collaboration with Quality and Regulatory departments to ensure that all documentation meets audit and accreditation standards
• Collaborate with IT project management, enterprise IT architects, software engineers, and business owners to adapt required computer systems to companion diagnostic products
• Provide system control and operational protocol recommendations
• Ensure that projects are well defined, clearly documented, and adhere to QSR and FMI processes and standards
• Clearly defines and communicates project and program resource requirements and drives transparent prioritization and coordination of CDx development projects

• Experience working with the FDA submissions such as PMAs, 510ks and IDEs
• Demonstrated success leading cross-functional teams and collaborative projects
• A minimum of three+ years of laboratory experience
• Demonstrated project management and business analysis experience within the Diagnostics or Biotech industry
• Familiarity with GxP and firm grasp of validation documentation skills and principles: IQs, OQs, PQs and lab process validations
• Excellent verbal and written communication skills
• Demonstrated ability to expertly lead groups to consensus in defining complex system and workflow requirements

• Experience working with typical oncology specimens (e.g. FFPE, Blood, Bone Marrow)
• Experience operating complex instrumentation (NGS, qPCR, lab automation)
• Experience in a Quality System Regulations (QSR) compliant laboratory preferred but not required
• Experience working in a startup environment
• Ability to manage direct reports in project management or business analysis roles, as needed
• Ability to step in and fill gaps in project resourcing by being a contributor

• PhD, or MS,with several years of experience, in Molecular Biology, Biochemistry, Genetics, Cancer Genomics is preferred
• PMP Certification is a plus

Apply Here

PI92729786

Foundation Medicine is seeking a talented, highly motivated and results-oriented Scientist/ Research Associate with a strong background in molecular biology, next generation sequencing and clinical assay development to join the Biomarker and Companion Diagnostic Development group. The ideal candidate has a working understanding of molecular biology and regulated laboratory (CLIA/CAP) experience in a high-throughput environment. Responsibilities of this position include supporting the development and optimization of new and existing NGS-based clinical diagnostic tests. The ideal candidate will be committed to the collaborative development and delivery of high quality and innovative clinical-grade genomic profiling assays in oncology specimens.

• Optimize and implement NGS-based clinical tests, including targeted DNA-seq, in collaboration with the Clinical Operations, Process Engineering, Computational Biology, Molecular and Biology Sequencing and Quality Assurance teams in a QSR/GMP environment under FDA regulations and guidelines
• Establish performance parameters, quality control and stability specifications for critical reagents
• Identify and qualify vendors for reagents
• Assist in vendor audits in collaboration with Quality Assurance team
• Support the timely processing and reporting of oncology samples to internal and external collaborators.
• Author detailed, accurate, and accessible records of experimental data, present results at group meetings, to external collaborators, and preparation of reports for submission to regulatory agencies (FDA)

• Experience in standard molecular biology techniques (PCR, enzymatic manipulation of DNA/RNA)
• Development, optimization, validation and implementation of CLIA-certified tests including writing SOPs and validation plans/reports

• Experience working with typical oncology specimens (e.g. FFPE, Blood, Bone Marrow)
• Experience operating complex instrumentation (NGS, qPCR, Bioanalyzer, lab automation)
• Experience in a Quality System Regulations (QSR) compliant laboratory preferred but not required

• BS, MS, or equivalent, in Molecular Biology, Biochemistry, Genetics, Cancer Genomics is preferred
• Minimum 3-5 years working in Industry and/or Academia in a laboratory setting
• Demonstrated track record of timely completion of projects
• Demonstrated written and oral presentation skills
• Demonstrated ability to work independently and collaboratively in a dynamic, fast paced team environment

Apply Here

PI92729790

Foundation Medicine is leading a transformation in cancer care, where each patient's treatment is informed by a deep understanding of the molecular changes that contribute to their disease.

The QA team at Foundation Medicine works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and support a diverse array of projects and initiatives. This is a unique opportunity to contribute to QA activities across multiple quality system requirements (CLIA/CAP and FDA regulated environments).

The Quality Assurance Manager will be responsible for planning, directing, and implementing programs which best fit the needs of FMI's Quality Systems and our patient-focused quality culture. The role requires strong regulatory knowledge and the ability to deliver results on schedule in a fast-paced and dynamic environment. Candidates must be detail-oriented with excellent organizational skills, able to assess new challenges and prioritize accordingly.

Located in the heart of Cambridge, MA—the world's preeminent biotechnology hub—Foundation Medicine offers competitive salaries, generous benefits and ample opportunities for professional growth.

• Assist in development and implementation of FDA compliant (QSR) Quality System; may take lead on elements of QSR implementation.
• Implement and maintain internal and external vendor audit program, manage approved supplier list, and lead vendor audits. Some travel required (approximately 10% annually).
• Provide QA oversight for materials management program and sample inspection process for all incoming materials.
• Provide review and feedback on validation plans and reports.
• Ensure proper management of deviations and perform routine review of incident and deviation logs.
• Assist with batch record review for final release activities.
• Demonstrate strong proficiency in the application of the Corrective and Preventive Action (CAPA) system to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources.
• Generation and reporting of required Quality Metrics and data for Management Review to meet regulatory requirements.
• May provide supervision of QA associates/specialists.
• Responsible for maintaining, updating and versioning of policies and protocols.
• Ensure that record keeping under FDA/GLP requirements is attributable, legible, contemporaneous, original and, above all, accurate.
• Manage employee training files:
  • Review credentials to ensure compliance
  • Manage training matrix

• Experience or familiarity with Companion Diagnostics
• Scientific background in molecular biology and/or NGS highly desired
• Experience with managing QA activities across multiple quality system requirements (e.g. operating under both FDA CFR Part 820 and CLIA/CAP)

• BS with 10 years, MS with 7 years or PhD degree with 5 years preferred with experience in the pharmaceutical, biotechnology, or diagnostic industries, at least 2 of which should include direct QA experience.

Apply Here

PI92729818

Foundation Medicine is seeking a Regulatory Affairs Sr. Manager. This position will lead RA activities at Foundation Medicine to support development and submission of materials to the FDA and other regulatory authorities, including the EU. This role will have the unique opportunity to contribute to the development of the regulatory strategy in the rapidly growing field of diagnostic next generation sequencing. This position will interact regularly with the FDA through the pre-submission and submission process.

• Represent RA as the regulatory representative in product development process to develop and execute regulatory strategies
• Prepare FDA submissions including Pre-submission documents, IDE applications, 510(k) applications, premarket notifications/applications and post-market reporting
• Assist in development and implementation of FDA compliant (QSR) Quality System

• Must have strong regulatory compliance knowledge of FDA IVD requirements
• Direct FDA (CDRH) interaction including written correspondence, informal communication (e.g. phone discussion with reviewers) and face-to-face meetings
• Must be detail oriented with excellent prioritization and organizational skills
• Superior technical writing skills
• Strong understanding of RA operations activities
• Must be able to deliver results on schedule in a fast-paced, dynamic environment
• Ability to manage RA project timelines to ensure that deadlines are met
• Ability to manage direct reports

• Experience in the diagnostics industry required, IVD experience preferred.
• Experience with submission of molecular genetic type assays, highly novel technologies preferred and/or Companion Diagnostic highly preferred, but not required.
• Experience with EU IVD regulatory requirements

• BS or MS preferred with at least 7 years of experience in the pharmaceutical, biotechnology, medical device, or diagnostic industries, at least 5 of which should include regulatory affairs experience. Experience with FDA submissions is required. Title is flexible depending on experience

Apply Here

PI92729824

RXi is looking for a talented scientist to join our interdisciplinary team working on development and evaluation of novel topical delivery platforms for skin and eye.  The successful candidate will play a major role in the evaluation and optimization of RNAi compounds and topical delivery technologies.  Working in collaboration with chemistry and pharmacology as well as external resources, the Research Scientist will design and screen a wide range of formulations and chemistries, facilitating the advancement of RNAi compounds into development. 

Key Responsibilities:

• Interdisciplinary team project management
• Design and screen a variety of compounds/formulations for optimized RNAi delivery in vitro and in vivo
• Develop and run a variety of assays to evaluate chemistry/formulations
• Establish and manage collaborations
• Assemble documentation for lead compounds/formulations transfer into development

Qualifications:

• Ph.D. in Biochemistry, Chemistry, Pharmaceutics or relevant field with 2-5+ years of postdoctoral or industry experience
• Previous experience with HPLC, in vitro assay development, and drug formulation is required
• Previous experience with tissue culture, oligonucleotides, and skin penetration assays is desired
• Excellent written and oral communication skills

RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering and developing innovative therapeutics, primarily in the areas of dermatology and ophthalmology, addressing high-unmet medical needs. Our discovery and clinical development programs are based on siRNA technology as well as immunotherapy agents.  These compounds include, but are not limited to, our proprietary, self-delivering RNAi (sd-rxRNA®) compounds for the treatment of dermal and retinal scarring. It also includes an immunomodulator, Samcyprone™, a proprietary topical formulation of diphenylcyclopropenone (DPCP), for the treatment of such disorders as warts, alopecia areata, warts, and cutaneous metastases of melanoma.   RXi’s robust pipeline, coupled with an extensive patent portfolio, provides for multiple product and business development opportunities across a broad spectrum.

We are actively looking for individuals with an entrepreneurial spirit and a drive for excellence to join our exceptional team.  We truly value our employees and make a significant investment in them by offering comprehensive, competitive compensation and benefit programs including incentive bonuses, stock options, health, disability and life insurance, 401(k) plans, paid holidays, paid time off and an ESPP. 

Please respond by sending a cover letter indicating the position of interest along with your resume to hr@rxipharma.com. You many also send to:

Human Resources

RXi Pharmaceuticals

257 Simarano Drive

Marlborough, MA   01752

No agency calls or submissions.

OBJECTIVES:
• Under the direction of their manager, executes and manages clinical trial supply activities for ongoing and planned less complex and phase 1 clinical trials. These activities include but are not limited to, study supply purchasing and procurement, tracking and maintainting inventory, shipping and receiving of clinical trial materials.
• Interacts with both internal and external customers and suppliers in order to accomplish project objectives. Monitors inventory levels and provides feedback to management/team members regarding expiry and re-supply, as necessary. Supports the activities of clinical operations and works closely with study teams.
• Under guidance of manager, recommends the distribution strategy for less complex studies to ensure milestones are met and then executes and resolves issues relative to the defined strategy.


ACCOUNTABILITIES: 
• Under the direction of manager, executes and manages clinical trial supply activities for ongoing and planned simple and phase 1 clinical trials. Study supply purchasing and procurement, tracking and maintainting inventory, shipping and receiving of clinical trial materials.
• Executes clinical supply plans , based on clinical study protocol and clinical development plans with oversight from manager.
• Responsible for scheduling and delivery of CTM including strategies for creating label and packaging design, randomization, packaging, labeling and distribution of clinical supplies. 
• Monitors vendors to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements. Ensures that key project milestones are met; with oversight from manager, communicates supply plan timelines to internal and external customers and partners.
• Assists in development of IVRS supply strategy; utilizes system to manage supplies to ensure uninterrupted clinical supplies throughout the duration of clinical studies.
• Monitors the logistic activities of project(s) supply chain, including GMP bulk shipments across the supply chain (API, DP, FG). 
• Ensures uninterrupted supplies throughout the duration of a clinical study program. Tracks inventory of available clinical supplies and tracks expiration dates. Coordinates with CMC, Clinical Operations and QA partners to manage technical and quality issues to facilitate uninterrupted supplies.
• Maintains and ensures compliance to all SOPs. 
• Participates in process improvement teams as appropriate.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 
Required:
• Bachelor’s Degree – preferred in health sciences, Biology, Chemistry, Nursing, Pharmacy or equivalent experience. 
• General familiarity of global R&D processes.
• Ability to manage multiple projects simultaneously.
• Ability to maintain accurate records and files. 
• Demonstrated track record of creativity and problem solving..
• Ability to exercise independent judgment .
• Demonstrated ability to work effectively in a global/matrix environment. 
Skills:
• Analytical Skills -ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and recommends possible solutions to the problem
• Organizational Skills-ability to balance multiple projects with appropriate prioritization
• Communication Skills – demonstrated ability to express one’s self clearly and concisely to colleagues and team members of the phone or face to face; raise challenges to manager; adjust language and/or terminology appropriate for the audience.
• Compliance Analysis – ability to review systems, processes and policies to ensure compliance with required good manufacturing and clinical practices
• Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals. The ability to handle many conflicting priorities is critical to build and maintain credibility and respect across the many different constituents in the supply chain.
• Presentation Skills- ability to give professional and concise presentations at internal and external meetings.

The Human Resources Business Partner (HRBP) will take a consultative approach in collaboration with business managers on a variety of human resources- related issues to include organizational effectiveness, change management, performance management and compensation. The HRBP formulates partnerships across the HR function to deliver value-added service to management and employees that reflect the business objectives of the organization. The HRBP will partner with Legal, IT and other HR team members and support the Research and Development, Medical Affairs and Clinical Development organizations.

• Models, and reinforces FMI's culture by ensuring that HR practices are aligned with organizational objectives and cultural pillars.
• Drives creation of policies, procedures and processes on global HR activities such as compensation, benefits, performance management
• Advises and partners with Leadership Team Members and their Teams on organizational and human resource issues and proactively identifies needs and develops and implements appropriate approaches, processes and tools.
• Work with the HR Team to develop global HR programs/processes to support overall effectiveness of the business.
• Manages employee relations issues such as employee g, workplace grievances, allegations, and work/performance issues while ensuring legal compliance across regions, leveraging employee abilities and managing risk. Effectively investigates issues, makes recommendations, and takes appropriate action. Partners with the legal department as needed/required.
• Coaches the leadership teams to enhance their impact on employees to address organizational needs (building morale, strengthening retention, and providing guidance on workforce and succession planning/career ladders).
• Serves as liaison with Talent Acquisition team to ensure workforce planning, recruiting and hiring strategies are met. Provides guidance on promotions and transfers.
• Identifies training needs for business units and individual coaching needs to support overall effectiveness of the business.

• Strong Business Acumen and working knowledge of multiple human resources disciplines; including but not limited to compensation, benefits, talent/performance management, employee engagement, reward and recognition principles and federal and state respective employment laws.
• Experience supporting science and medical teams in a life science environment.
• Willingness to travel globally.
• The ability to think strategically and still maintain an attention to detail.
• The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast paced environment
• Able to command respect at all levels of the organization, capable of highly-independent work as well as being a team player and role model
• Strong interpersonal skills; experience in effectively communicating with employees, senior management or other outside partners.
• Excellent verbal and written skills, able to lead open and effective dialogue throughout the Company and able to craft and deliver compelling messages internally.

Education or Experience:

• 7-10 years HRBP or Generalist experience. PHR/SPHR preferred.
• Demonstrated track record of proactively suggesting new alternatives to current HR practices, anticipating and developing both strategic and tactical HR plans and programs to accomplish the Company's mission
• Experience in most or all of the functional areas associated with this position; excellent management, negotiating and organizational skills; demonstrated ability to achieve results
• High energy level, a driving sense of urgency and a seasoned “make it happen/can do” orientation
• Experience working in multi-state and global organizations is preferred

Apply Here: http://www.Click2Apply.net/jxgfmx3pn4

PI92729882

Foundation Medicine is actively seeking a Operations Associate, Strategic Alliances to provide comprehensive operational and tactical support for the company's pharmaceutical alliances. The candidate will be responsible for implementing, and monitoring the execution plans for each of our pharmaceutical relationships, including day to day project management of clincal studies, project tracking and resource management. The individual is expected to work primarily with internal and to some extent external resources to manage timelines, resource plans, critical path activities and risks.

• Assists with management of the day-to-day operational and tactical aspects of our clinical pharmaceutical customers
• Ensures that appropriate progress is being made against defined strategies; proactively identifies and raises issues and provides recommendations for resolutions.
• Regularly and proactively considers challenge points and opportunities for acceleration, and communicates to the stake holders.
• Creates team agendas and documents meeting minutes.
• Applies project management tools and techniques to support the establishment of detailed operational plans in alignment with program development strategies.
• Supports collaboration with team members and assists in building presentations to support recommended courses of action.
• Ensures appropriate follow-up of all team members in the execution of tactical objectives and escalates issues to the appropriate parties.

• BS in a business or scientific discipline.
• (Associate) 1+ year professional experience in the biopharmaceutical or diagnostic industry or a comparable position in clinical trials, regulatory affairs in an academic cancer center.
• (Senior Associate) 2-3 years professional experience in the biopharmaceutical or diagnostic industry or a comparable position in clinical trials, regulatory affairs in an academic cancer center.
• Confident, proactive individual capable of taking the initiative and driving to results.
• Strong organizational skills in order to maintain a high level of productivity innovation, and setting priorities in order to complete assignments in a timely manner and within budget.
• Demonstrated evidence of success working in a cross-functional environment; able to build strong relationships
• Exhibits high initiative, strong drive and follow-through.
• Competency in MS Office; expert in MS Project.

Apply Here

PI92729881

Foundation Medicine is seeking an attorney with knowledge and experience in corporate law, compliance and commercial transactions to work closely with the other members of the legal and compliance teams at Foundation Medicine. This attorney will have a key role in advising business units within Foundation Medicine and working with the contracts management team to draft and negotiate a broad range of contracts for various business units. The preferred candidate would be a corporate attorney with familiarity handling a broad range of life science issues, with prior work experience at a life sciences company and/or a law firm with life sciences clients. All candidates must be able to work in a dynamic, evolving and fast-paced work environment, with the confidence and abilities to work independently and to interact successfully with internal clients and external parties. The Corporate Counsel/Corporate Attorney will report to the Associate General Counsel.

• Assist Foundation Medicine's legal and compliance teams with general corporate, compliance, regulatory and other legal matters relevant to Foundation Medicine's operations, including U.S. and ex-U.S. operations.
• Draft, revise, and negotiate general corporate, operational and commercial agreements relevant to Foundation Medicine's day-to-day operations, including services agreements, payor agreements, vendor agreements, research agreements, clinical trial agreements and consulting agreements.
• Collaborate with Foundation Medicine's head of compliance to implement the compliance program, including developing and managing auditing programs.
• Collaborate with Foundation Medicine's Senior Manager for Legal Services to manage Foundation Medicine's contracting process

• Ability to quickly and effectively spot complex legal issues, research new legal issues, and provide advice in a manner that integrates legal risk management with Foundation Medicine's business objectives.
• Experience drafting, revising and negotiating services and commercial agreements.
• Strong oral and written communication skills and sound business judgment.
• Ability to balance a variety of projects with deadline pressure and limited supervision, identify and escalate legal issues when needed, and work collaboratively with business unit and legal department colleagues.

Education, Experience and Bar Admission:

• 2-5 years of legal experience with general corporate agreements. Ideal candidate would have experience as an in-house attorney at a life sciences company and/or experience in a law firm setting representing life sciences companies. Experience with the diagnostics industry and commercial products is a plus.
• JD and admission to the Massachusetts Bar.

Apply Here

PI92729873

Position Summary
This individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual updates, NDA annual reports, PBRERs). With oversight and guidance, contributes to the generation of product regulatory strategy documents (for products in phase 1-3 clinical development), labeling updates for marketed products, generation of FDA meeting requests and corresponding briefing materials, and other tasks as needed.

Requirements
Education and Experience:
Bachelor’s degree and at least 5 years in Regulatory Affairs or relevant industry experience, or
Master's, PharmD, PhD degree and 3 years in Regulatory Affairs or relevant industry experience.
Skills:
Working knowledge of FDA and ICH requirements for standard regulatory documents and their maintenance.
Excellent written and verbal communication skills, with ability to organize and manage multiple priorities.
Proficiency in MS Word, Excel, and PowerPoint.
Self-starter with the ability to work independently but seeking out guidance as needed.
Technical aptitude to work across multiple information systems and databases with ability to troubleshoot.
Sense of urgency and perseverance to achieve results.

Join bluebird bio’s enthusiastic and collaborative Quality Operations team to contribute to
the overall success of our novel gene therapy approach. This Quality Assurance
Compliance Specialist will support the organization by ensuring conformance to
established quality assurance processes and standards while actively working to continuously improve them. In this position you will be responsible for all aspects of 
batch review and closure, resolution of quality systems encountered while manufacturing and
testing, and generation of disposition documentation. Additionally you’ll support technical
transfer and process validation activities for a variety of bluebird projects from clinical
trials through commercialization.
About the position:
• Support bluebird bio Pharmaceutical Science during batch production,
ensuring unexpected events are handled compliantly
• Manage problems of diverse scope using a high degree of judgment and riskbased
decision making
• Review and approve documents including:
o Manufacturing batch records in support of product release
o Standard Operating Procedures, Stability Protocols and Reports
o Process and Method Validation Protocols and Reports
o Documents associated with deviations, investigations, OOS results,
and CAPA action plans
• Ensure all documentation complies with cGMP regulations and industry
guidelines
• Collaborate with Quality Assurance partner at CMOs and CTOs ensuring
quality issues are tracked and resolved in a timely manner
• Track and trend quality system generation at CMOs and CTOs, providing
period updates to Management – Review and approve deviations, CAPA, and
Change Control, performing Failure Mode and Effect Analyses, root cause
analyses, and CAPA effectiveness check as required
• Track and trend batch execution at CMOs, providing periodic updates to Management – alignment to target Turnaround Times and Disposition dates, number of comments and deviations per batch
• Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
• Engage in activities to continuously assess and improve Lot Review and Disposition processes
• Support the development, implementation, and revision of corporate quality systems
• Review relevant sections of regulatory filings
About you:
• BA/ BS and a minimum of 7+ years in Quality Assurance
• Experience with disposition, investigations, change control, and process qualification and validation
• Strong knowledge of GxP regulations, quality systems, and guidance documents
• Experience with contract manufacturing and contract testing organizations beneficial
• Ability to work with minimal supervision and effectively in a matrix-based organization
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
• Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines
• Lean Six Sigma Green Belt – preferable but not required
• Ability to travel minimally
• Be ready to embrace the principles 

The Sr. Manager/Associate Director of Training is responsible for ensuring that training programs are developed, implemented and effectively administered consistently, in a manner that maximizes efficiency, complies with industry standards, and achieves desired compliance targets.  Lead the development and implementation of training and continuing education programs throughout bluebird.  Thoroughly identify training and educational needs, articulate goals for meeting these needs, and identify creative, high impact and sustainable approaches for meeting these goals. Provide leadership and management of the training and development program to ensure that the appropriate training activities are developed and implemented in line with strategic objectives.    

About the position:

• Develop, manage and communicate bluebird bio’s training requirements and initiatives.
• Partner with internal/external groups, colleges/universities, and vendors to identify/implement innovative training solutions that help advance the efficiency, productivity, and technical depth of site personnel.

• Provide technical expertise to ensure high quality training programs.
• Provide innovative ideas to advance training effectiveness and share best practices.
• Administrator of bluebird bio’s Learning Management Systems (LMS).
• Responsibilities include oversight of program design, Learning Management System, logistics, delivery, metrics and maintenance
• Providing timely and metric driven updates on the status of training programs
• Ensure that training and continuing education programs are appropriately reviewed, technically sound, and aligned with site goals and corporate training philosophy
• Foster a quality mind-set within Quality and throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.

Requirements:

• Bachelors’ and/or Masters’ degree in scientific discipline. Technical understanding of biopharmaceutical production.
• A minimum of ten (10) years of experience in the industry, ideally early clinical phases through commercial drug product.
• Knowledge of US and EU cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
• Skills to lead cross functional teams.
• Strategic experience with senior leadership team level clients, strong decision making capability.
• Strong leadership and management experience with ability to work in a matrix environment.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
• Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
• Ability to travel approximately 20%
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

Success Factors:

• Ability to motivate and lead.
• Effective cross-functional partnering.
• Risk management experience (FMEA, PHA, etc).
• Project management experience.
• LEAN/Six-Sigma training.
• Experience with regulatory inspections and audits.
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
• Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.   This role reports into the Associate Director, Procurement and will be tasked with managing the Procurement Operations function within bluebird bio, helping to implement Oracle Cloud “Self-Service Procurement” and serving as a key customer service resource across the business.  The right candidate should be highly motivated and have strong communication and interpersonal skills with a shared commitment to helping people focus more time on science and less on purchasing, ordering and working with vendors.

About the role:

• Managing and supporting company’s new centralized Procurement Operations function
• Assisting project team with implementing and testing new Self-Service Procurement (Oracle Cloud) system
• Administrating, managing & training end users on procurement systems & processes
• Reviewing purchase requisitions and appropriately converting to purchase orders (POs)
• Effectively performing supplier negotiations on one-off purchases that are not covered by an existing contract and monitoring all related cost savings
• In collaboration with internal stakeholders, resolving supplier quality and/or services issues as appropriate.
• Helping develop and manage a new procurement intranet page
• Establishing strong business relationships with suppliers and internal customer groups.
• Reviewing and negotiating purchasing terms and conditions and low risk vendor contracts
• Maintaining vendor master file

About you:

• BA or BS Degree
• 3 - 5 years of direct experience in a corporate procurement role
• Procurement systems experience, preferably in Oracle iProcurement or Self Service Procurement (Oracle Cloud)
• Independently motivated, detail oriented and good problem solving ability
• Excellent communications skills and ability to influence across multiple functions
• Experience working in or supporting pharmaceutical or biotech R&D preferred
• Willingness to embrace and demonstrate the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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.

Foundation Medicine is aiming to build a high-performing, experienced Medical Science Liaison Team to round out our highly respected Medical Affairs Team specifically related to developing and enhancing a strong network of Key Opinion Leaders (KOLs) to support the commercial and scientific efforts and objectives of the company. We are seeking multiple field-based, highly trained Senior Medical Science Liaisons and Medical Science Liaisons (MSLs) with strong clinical and/or scientific backgrounds and excellent communication skills to initiate and sustain an exchange of scientific information with key external customers and internal teams. Activities include conducting scientific presentations to health care providers, emphasizing the medical and scientific strengths of the company's existing products, well as with any future company development initiatives. The Sr MSL/MSL will address scientific questions, as well as promote and develop access to key thought leaders in their assigned region and utilize these relationships to collaborate where appropriate on educational and research opportunities. This position will report to the VP, Medical Affairs and will require approximately 70% travel. At this time we are considering candidates that are based in any location in the Continental United States.

• Function as a regional MSL specializing in Medical Affairs interactions and initiation and exchange of scientific information with key opinion leaders and other physicians in the oncology and pathology settings
• Facilitate education regarding FMI products in the hematology/oncology and pathology communities as a scientific expert through presentations and scientific exchange
• Help identify and establish relationships with key opinion leaders, clinical and research leaders including academicians, clinicians, medical directors and other HCPs, and provide regular support and education regarding disease state awareness and FMI clinical data
• Respond to scientific/genomic inquiries from HCP customers promptly
• Assist with identification of investigator initiated studies, guiding through the approval process, and monitoring study progress
• Facilitate involvement in national, regional and local scientific forums including symposia, tumor boards and training meetings
• Contribute to scientific messaging for promotional materials, provide competitive insight and work with managers to provide leadership and strategies to develop advocates for the company
• Develop and create materials such as slide decks, training materials, white papers, monographs, case report summaries, clinical synopses
• Integrate efforts with Medical Affairs for organization of scientific advisory boards, key opinion leader management, coordination of clinical trials, and execution of publication strategy
• Gather market intelligence on competitor products and new products in development.

• General understanding of the field of oncology; knowledge of oncogenomics and targeted therapy
• Fundamental understanding of principal cancer patient management algorithms and clinical utility of laboratory-developed molecular tests
• Familiarity with CLIA, LDT, Sunshine Act (2013), AdvaMed Guidelines
• Business acumen (market analysis, market access strategy, territory planning) combined with exceptional interpersonal communication ability
• Existing key opinion leader relationships a plus
• Ability to train/teach others
• Strong matrix management skills
• Ability to travel (domestic) extensively (~70%), often at short notice
• Self-motivated

Education and Experience:

• Advanced scientific or medical degree (PhD, PharmD, MD)
• Senior MSL – minimum of five (5) years or MSL – three (3) to five (5) years of work experience as an MSL in a diagnostics, biotech or pharmaceutical company.
• Oncology experience is a must

Apply Here

PI92729825

We are seeking a talented and highly motivated Senior Software Engineer to work closely with computational biologists, data analysts, and other engineers to design, develop, and support key pieces of production infrastructure. In addition, this individual will support research and development, building tools to facilitate data mining and methods development.

• Work with a group of software engineers and computational biologists focused on the analysis of next-generation sequencing data to characterize genetic alterations in tumor genomic DNA and RNA.
• Build and maintain robust pipeline infrastructure to run analysis in parallel on a large compute cluster
• Enhance, extend, and optimize a database of clinical genome variations and related quality metrics
• Develop and maintain web applications enabling production operations, search, and data analysis
• Expand data access APIs for ad-hoc analysis of large data sets
• Optimize systems for performance at scale

• BS in computer science, software engineering, or related field
• +3 years of professional Engineering experience
• Advanced knowledge of Java and Python
• Experience with version control systems (Git preferred)
• Experience with SQL, database design, object-relational mapping (ORM), and query tuning
• Experience with Spring, JPA/Hibernate, and Maven
• Experience building web applications, web services, and user interfaces
• Software engineering practices like test-driven and agile development

Desired Skills and Experience:

• Java 6 and 7
• HTML5, JavaScript, JQuery
• Google Web Toolkit (GWT)
• Message Queuing, ActiveMQ, and JMS
• Oracle Grid Engine and DRMAA
• XML, XSLT, XSL-FO, and JSON for data representation and transformation
• Implementing, profiling, and optimizing high-performance algorithms
• Prior experience in the life sciences domain is a plus

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PI92729836

The Director of Clinical Quality Assurance is responsible for managing a team of Quality Assurance professionals responsible for overseeing non-clinical and clinical activities related to GLP industry standards and regulations. The Director is responsible for assisting with the strategic alignment of group or team goals with projects and activities and refining those projects and/or activities proactively. This role is also responsible for technical development of personnel and ensuring the quality of deliverables within their purview. 
 
General Responsibilities and Required Skills:
•   Demonstrates the ability to successfully plan, adjust,
manage and optimize all resources for advancement of all goals and objectives.
•   Demonstrates strong aptitude for facilitating group or project team endeavors, and building team unity.
•   Demonstrates advanced ability to effectively communicate and influence the outcomes of the decision making process.
•   Displays highly developed organizational leadership qualities.
•   Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
•   Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GLP quality systems and management.
•   Helps craft department goals and ensure linkage to individual goals.
•   Displays highly effective coaching abilities as well as a successful track record of developing junior staff.
•   Conduct presentations on quality issues, initiatives and projects at cross functional meetings.
•   Approves work related travel and expense reports for members of their functional group. 
 
Key Responsibilities:
•   Development, implementation, and oversight of quality
activities in support of GLP activities conducted or monitored by Vertex Pharmaceuticals Inc. These activities focus around the qualification and monitoring of GLP Service Providers and performing duties required of an internal Quality Assurance Unit.
•   Collaborates with internal departments on strategy and implementation of quality principles and regulation requirements.
•   Provides Quality insight/feedback to internal departments. This may come in the form of SOP reviews and/or ad-hoc requests.
•   Development and reporting of compliance metrics related to GLP activities.
•  Coaches/mentors staff as a means to ensure performance and professional development.
•   Establishes/maintains effective cross functional team communications to advance quality activities of Vertex.
•   This position requires up to 10%-20% travel. 
 
Preferred Education And Experience:
•  M.S. in a scientific or allied health field and 8+ years of relevant
GLP QA work experience, or
•  B.S. in a scientific or allied health field
and 10+ years of relevant GLP QA   work experience, or relevant comparable background.
•  5+ years’ experience serving in a Quality Management role.
•  Has an excellent understanding of operational GLP’s.
•  Managerial experience in planning and personnel development is required.
•  Demonstrated leadership skills are critical to this role.
•  Proficiency in using Microsoft Office applications required (MS Word, MS Excel, Trackwise, MS PowerPoint).