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.  This will be part of the Site leadership team and will oversee a team of direct and indirect reports totaling in the range of 120 - 150 staff.

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.