Head of QC Virology

  •  

Waltham, MA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 12 days ago

  by    Breeana Cebula

Our growing Gene Therapy client is expanding and adding a Director, Virology QC to their team! They are based in Cambridge, MA and the role will move out to the Waltham, MA area to help build out a new, state of the art lab! This role will build, review and trend development, GMP and stability data, generating reports as necessary to document these activities.  The Director of QC will also support the development and implementation of GMP quality systems to ensure that company is in compliance with US and international regulations, laws, and guidelines that oversee the manufacturing and testing of investigational clinical trial materials by authoring appropriate SOPs and implementing training programs to support QC and related GXP processes. The Director of QC- Virology will specifically support the gene therapy program pipeline including but not limited to oversight and management of technical transfer, method qualification and/or validation and routine GMP testing of AAV vector and AdV analytical methods (qPCR, TCID50, and other methods as needed) and support viral clearance studies. The Director will manage external laboratory testing and internal study protocol design, study report review and IND support as needed.

 

Ensure successful technical transfer, method qualification, troubleshooting and routine GMP testing for qPCR, cell-based infectivity, and virus detection assays. Engaging with in-house teams and external QC test labs and CMOs, oversee and manage: QC data review, method validation activities, protocol review and report finalization.

 

Responsibilities

  • 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

Requirements

  • BS or MS or Ph.D. in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 8+ years industry experience
  • Experience developing and qualifying biological methods in one of the following areas: immunoassays, cell-based assays, QPCR assays, and microbiological 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

$156K - $204K