Our growing Gene Therapy Client is looking to add a Sr. Research Associate / Scientist, Molecular Biology to their QC Virology team! This role will support the gene therapy program pipeline including but not limited to technical transfer, method qualification and/or validation and routine GMP testing of AAV vector analytical methods (qPCR, DD PCR, and other methods as needed) for lot release and stability. Also support external laboratory testing, internal study protocol design, study report review and IND support as needed and support technical transfer, method qualification, troubleshooting and routine GMP testing for molecular assays, including particle titer by qPCR or DD PCR, and residual DNA test methods. Engage with in-house teams and external QC test labs and CMOs to support QC data review, method validation, protocol review and report writing.
- Support the development, technical transfer and validation of molecular methods
- Support the development 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 root cause analysis.
- Work with cross functional teams
- BS or MS in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 4+ years industry experience
- Experience developing and qualifying PCR methods
- Experience drafting protocols, data reports and QC/QA compliance documents
- Experience with statistical analysis of analytical data and stability studies 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