Quality & Regulatory

QC Manager - Lab Operations Direct Hire MA

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Job ID: 15509 Direct Hire MA

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Mid-Size Biologics company here in Cambridge, MA is growing and looking to add a QC Manager - Lab Operations to their Team!  QC Manager will work closely with QC Leadership and support the build-out of a new commercial-level, in-house GMP Sample Control and testing laboratory!  This lab will support the release and stability for multiple stages of gene therapy and immune oncology products. Other responsibilities include:

  • Manage and build Sample Control for GMP Release, Stability, Extra Test Samples
  • Establish GMP Reference Standard/Assay Control and Critical Reagents Inventory Control and manage Consumables/Reagents
  • Lead and/or review Equipment/Instrument IOQ/PQ (vendor/company)
  • Manage and prepare POs for GMP CTO Release Testing
  • Coordinate Release, and Stability cGMP analytical Testing and Review for Appearance, pH, bioassay, flow cytometry, qPCR, HPLC, and ELISA)
  • Author, review, and/or approve SOPs/policies and technical reports
  • Implement and manage equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, lab cleaning, cGMP documentation, LIMS
  • Participate and/or lead in providing the necessary information for regulatory filings and inspections.
  • Lead and support CAPA/Continuous Improvement Initiatives

Requirements:

  • BS or MS in a scientific discipline, 10+ years of related experience in QC GMP testing
  • cGMP operational and technical background in cell biology, biochemistry, and/or molecular biology
  • Experience with implementation/managing QC GMP equipment/instrument annual performance verification/calibration/maintenance, monitoring, alarm notification, and qualification, data back-up; data archival of analytical data

QC Sr. Manager, Biochemistry Direct Hire MA

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Job ID: 15370 Direct Hire MA

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QC leadership opportunity now available at one of the state's top biopharma campuses, producing commercial and clinical biologics.  Great opportunity to join an experienced QC Director and established team to support in-process, release and stability testing of biologic therapeutics.  

The main function of this role is to lead biochemistry laboratories performing a broad range of biochemistry-based QC techniques such as enzyme assays, PCR, SDS-PAGE, and compendial testing for both clinical and commercial products.   

Responsibilities include but are not limited to;
•  Provides leadership on a daily basis to ensure routine testing is performed in accordance with company goals and committments
•  Support method transfer and validation activities for commercial and clinical testing 
•  Introduction of new equipment and technology 
•  Identify and mitigate compliance risks and communicate with various projects teams

Formal descriptions and information on the company, hiring manager, etc. can be disclosed to interested candidates. 

Qualified candidates will have a BS degree or higher and 10+ years of industry experience in a cGMP QC setting supporting in-process, release and stability testing of biologic therapeutics.  Demonstrated experience leading large team is essential to be considered.  

Must be authorized to work in the US indefinitely to be considered and must be commutable to the suburbs of Boston & Cambridge or able to relocate with limited assistance.  

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