Quality & Regulatory

QC Stability/Lab Operations Leader, Biologics Direct Hire MA

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Job ID: 14751 Direct Hire MA

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Our client is one of the top gene therapy companies here in the Cambridge/Boston area and are seeking an experienced QC leader to head up both the QC Stability program as well as QC Lab Operations (laboratory equipment management, sample and reagent management, reference material management).

The main function of this role is strategic management of stability programs for ancillary materials, starting materials and drug products, and to lead a team managing QC laboratory equipment, reagents, sample, information and reference material programs.

Responsibilities include but are not limited to;
•  Build a risk-based stability program in support of their early and late-phase clinical development programs.
•  Originate ICH compliant stability protocols and reports and hands-on leadership of the QC Stability function
•  Trend stability data and establish retest and expiration dates 
•  Collaborate with Quality management and external partners/CTOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
•  Prepare and review CMC stability sections for clinical regulatory filings, MAA, and BLA

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have BS or MS degree in a Life Sciences discipline and 10+ years of industry experience in a GMP QC setting.  Must have experience with biologic therapeutics (cell and/or gene therapy products a plus) and strong knowledge of cGMP/ICH/FDA/EU regulations.  Must also have understanding of statistical analysis as it relates to product stability trending and experience with statistical software packages such as JMP.  Experience with LEAN/Six Sigma is highly desirable but not required.  

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area.  Relocation assistance available for qualified candidates.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

QC Manager/Group Leader, Technical Services Direct Hire MA

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Job ID: 14661 Direct Hire MA

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One of the largest and fastest-growing biotechnology companies in the Boston area is actively seeking an experienced Manager/Group Leader to join their QC Technical Services group.  Our client has several approved products on the market
and a robust pipeline of new biologics in development.  This will be based at their campus in the suburbs of Boston/Cambridge at one of the key sites for this global company.  

In this role, you will lead a small team responsible for non-laboratory activities that ensure overall effective QC operations. Additionally, the role supports Quality projects and implementation of operational excellence initiatives. 

Responsibilities include but are not limited to;
• Lab scheduling, metrics reporting, non-routine protocol review, and QC archiving.
• CoA generation and specification management for drug substance and drug product 
• Support inspection preparation activities as well as provide resources for inspection management 
• LIMS builds in support of analytical and/or process development or investigational programs 
• Oversight of storage of retains, reserves, and reference standards for internal programs and specified external programs 
• Monitor QC cold storage capacity and ensure sustainability for storage of an expanding portfolio
• Coaching and development of junior staff.    

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have BS degree or higher in a life-science or engineering discipline and 10+ years of experience in a cGMP manufacturing or quality environment.  Experience with LIMS or LEAN/Six Sigma methodology a plus but not
required.

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Head of Quality Direct Hire MA

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Job ID: 14596 Direct Hire MA

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Quality Assurance leadership opportunity at one of the state's top biopharma campuses, producing commercial and clinical biologics.  

The main function of this role is to lead design and execution of the strategy for compliance to Good Manufacturing and Good Distribution Practices for manufacturing, research, and warehouse operations at a multiple sites in the suburbs of Boston.  

Responsibilities include but are not limited to;
•  QA oversight and compliance of: quality systems (change control, CAPA and deviations); audit support; plant QA operations; internal product technology transfer; and facility compliance. 
•  Responsible for bulk drug substance manufacturing/ testing oversight and final lot disposition for commercial and clinical (DS specific) use. 
•  Responsible for review and approval of site validation activities. 
•  Responsible for Quality Control site testing including raw materials, environmental monitoring, and microbiology and oversight of related investigations.
•  Overall responsibility for cross-plant quality alignment.    
•  Lead and coach direct team and drive a high performance organizational culture that accommodates rapid growth and highly dynamic expectations
•  Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group.
•  Ability to lead complex material review boards to determine the ultimate outcome of complex deviations/dispositions which are based on data, science, and compliance
•  Creation and management of the Site Master Files & management of site (plant) licensures

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a Degree in technical discipline such as biochemistry, chemistry, engineering and at least 15+ years of experience in the biotechnology and/or pharmaceutical industry with experience leading large Quality teams (50-100+).  Must also have track record of effective Quality leadership for internal production facilities, testing, sampling, and product disposition and experience in providing Quality oversight for engineering and validation projects supporting internal operations and tech transfer activities.  

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Greater Boston area.  Relocation assistance available for qualified candidates.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Head of External QA Direct Hire MA

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Job ID: 14588 Direct Hire MA

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QA leadership opportunity at one of the state's top biopharma campuses, producing commercial and clinical biologics.  The scope of operations includes external activities performed globally in support of biologic drug substance, drug product and finished drug product and product disposition of same including related medical devices.  

The main function of this role is leading, monitoring and supporting the performance of quality systems according to company standards in support of external Biologics products.

Responsibilities include but are not limited to;
•  Provide direction and leadership to the external Biologics Quality Systems team and support the greater organization with matters of GMP compliant global operations which include DS manufacture, drug product manufacturing, laboratory operations, packaging and labeling operations and batch disposition. 
•  Working internally with the Heads of disposition, QA Operations and Site Compliance Lead to support external Biologics Quality and QA leaders globally in each operating site to influence and affect the necessary operations managed through the local leadership teams. This position is responsible for ensuring consistency of Quality Systems across external Biologics Quality and for driving efficiencies. 
•  Accountable for rapid escalation and cross functional evaluation of quality alerts and incidents which occur across the external Biologics operations; participation in Tech Ops governance meetings, ensuring appropriate escalation of trigger events; deployment of Global Quality Standards within the function
•  Responsible for; global quality defect reporting ie Biological Product Defect reports and Quality Defect Reports; all non CMO/CTL deviations, CAPAs and Change Controls including determination of root cause and identification of appropriate CAPAS; providing feedback on implementation of the Quality Systems in external Quality Biologics to the Business process owners (BPOs); deployment of the risk management process in external Quality Biologics and for establishing risk champions; supporting the Bio Quality management reviews
•  Manages the processes for both Material Review Board(MRB) and Non Conforming Material Reports (NCMRs) 
•  Provides training support to the external Quality Biologics teams
•  Responsible for managing and reporting on Quality metrics and leading the effort to drive improvement
•  Responsible for building and developing a highly functioning global quality system team and driving a high performance organizational culture that accommodates rapid growth and highly dynamic expectations.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree in chemistry, biology or a related discipline and 10+ years experience working in a Quality Systems role in the biotechnology and/or pharmaceutical industry, preferably in manufacturing/operations.  Must have a thorough understanding of quality systems, cGMPs, GDPs and experience with Aseptic/Sterile Processing and Packaging and labeling.  Must be proven people manager and leader capable of developing people and teams with at least 10 years of management experience. 

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Greater Boston area.  Relocation assistance available for qualified candidates.   

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

QC Manager, novel biologics in clinical development Direct Hire MA

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Job ID: 14529 Direct Hire MA

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Team development in support of a novel biologics platform at one of the most highly regarded mid-size start-ups in Cambridge.  

The main function of this role is to manage all activities associated with QC release testing for starting materials and Drug Product disposition. You will be responsible for management of QC testing for clinical trial material through to commercialization including technology transfer and CMO/CTO management. 
 
Responsibilities include but are not limited to;
•  Lead QC activities for technology transfer of manufacturing and testing processes to external CMO/CTOs.
•  Management of the following activities; release and stability testing for starting materials and drug product; data review, analysis, and identification of trends; assay troubleshooting and identifying and implementing improvements to existing assays
•  Prepare, execute, and review deviations, change controls, CAPAs, OOT/OOS and prepare and review CMC sections.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree in a scientific discipline plus 6+ years of related experience in QC GMP environment (2+ years in a management role) and experience with technology transfer and CTO/CMO management.  Must have strong QC Analytical knowledge and cGMP/ICH/FDA/EU regulations in a biologics setting. Experience with cell culture, flow cytometry, and qPCR preferred. 

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Greater Boston area.  Relocation assistance available for qualified candidates.   

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.