Quality & Regulatory

Director, Virology QC Direct Hire MA

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Job ID: 15769 Direct Hire MA

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Director, Virology QC                                               

Mid-Size Gene Therapy Company here in Cambridge is growing!  They are looking to bring on board a Director, Virology QC!  This role will support/lead the Viral Clearance program, including managing external laboratory testing and internal study protocol design, study report review and IND support as needed.  Will ensure the successful technical transfer, method qualification, troubleshooting and routine GMP testing for gene therapy qPCR assays, including but not limited to Ad5 and AAV qPCR. Engaging with in-house teams and external QC test labs and CMOs, oversee and manage viral clearance validation studies, including protocol review and report finalization.  Other responsibilities include but not limited to: 

  • Oversee the development, technical transfer and validation of qPCR and cell based viral assays.
  • Support the development and management of QC specifications for in-process, release and stability testing programs
  • Work independently to review and trend QC data, generating stability and other trending reports as necessary
  • Prepare, analyze and trend QC data
  • Prepare stability reports
  • Support the development of QC systems and SOPs, such as sample management, shipping, release testing and laboratory investigations.
  • Support QC deviations, investigations, analytical method performance trending and work with external testing laboratories on investigation actions and root cause analysis.
  • Work with cross functional teams to drive these initiatives forward

Qualifications

  • BS or MS in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 8+ years industry experience
  • MUST have experience developing and qualifying biological methods for viral cell-based assays and/or QPCR assays
  • Experience drafting protocols, data reports and QC/QA compliance documents required
  • Experience with statistical analysis of analytical data and stability studies preferred
  • Experience with viral vectors is not required but experience with biologics preferred
  • Ability and desire to work in a fast-paced, start-up environment
  • Strong collaboration, team-working skills and communication skills
  • Independently motivated and detail-oriented with good problem-solving ability

Principal Scientist, Virology QC Direct Hire MA

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Job ID: 15768 Direct Hire MA

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Principal Scientist, Virology QC                                               

Mid-Size Gene Therapy Company here in Cambridge is growing!  They are looking to bring on board a Principal Scientist, Virology QC!  This role will support/lead the Viral Clearance program, including managing external laboratory testing and internal study protocol design, study report review and IND support as needed.  Will ensure the successful technical transfer, method qualification, troubleshooting and routine GMP testing for gene therapy qPCR assays, including but not limited to Ad5 and AAV qPCR. Engaging with in-house teams and external QC test labs and CMOs, oversee and manage viral clearance validation studies, including protocol review and report finalization.  Other responsibilities include but not limited to: 

  • Oversee the development, technical transfer and validation of qPCR and cell based viral assays.
  • Support the development and management of QC specifications for in-process, release and stability testing programs
  • Work independently to review and trend QC data, generating stability and other trending reports as necessary
  • Prepare, analyze and trend QC data
  • Prepare stability reports
  • Support the development of QC systems and SOPs, such as sample management, shipping, release testing and laboratory investigations.
  • Support QC deviations, investigations, analytical method performance trending and work with external testing laboratories on investigation actions and root cause analysis.
  • Work with cross functional teams to drive these initiatives forward

Qualifications

  • BS or MS in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 5-7 years industry experience
  • MUST have experience developing and qualifying biological methods for viral cell-based assays and/or QPCR assays
  • Experience drafting protocols, data reports and QC/QA compliance documents required
  • Experience with statistical analysis of analytical data and stability studies preferred
  • Experience with viral vectors is not required but experience with biologics preferred
  • Ability and desire to work in a fast-paced, start-up environment
  • Strong collaboration, team-working skills and communication skills
  • Independently motivated and detail-oriented with good problem-solving ability

Lead the Particle ID lab! Direct Hire MA

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Job ID: 15601 Direct Hire MA

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Our client is a large biopharmaceutical company in the suburbs of Boston/Cambridge with multiple approved products on market.  They have built an in-house Particle ID lab to leverage state-of-the-art microscopy and spectroscopy tools 

The main function of this role is to serve as a Technical Lead and perform identity testing for particles found in the GMP manufacturing of biologics. Analytical techniques in this group will include polarized light microscopy (PLM), Fourier Transform Infrared Spectroscopy (FTIR) and Rap.ID Spectroscopy (RAMAN + LIBS), Scanning Electron Microscopy (SEM), . 

Responsibilities include but are not limited to;

•  Prepare particles for microscopy techniques and determine characteristics of particles using PLM, FTIR and RAMAN.

•  Trending of particles using historical data and review of data generated by junior staff

•  Coach/mentor junior analysts concerning new lab techniques and serve as a technical resource in the particle ID laboratory. 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher in a relevant discipline and 5 - 7+ years industry experience in spectroscopy and microscopy as applied to particle identification processes (manufacturing/product contact studies/etc.).  
The Hiring Manager has the flexibility to consider more experienced individual contributors as well, including PhD-level candidates.  Preference given to those with GMP, LIMS and/or past experience with statistical software (ex: JMP, Statistica).  

Must be authorized to work in the US indefinitely to be considered and must be commutable to the suburbs outside Boston & 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.

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.