Mid-Size Gene Therapy Company here in Cambridge is growing! They are looking to bring onboard 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
* BS or MS or Ph.D. in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 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