This individual will support quality control activities conducted at Sarepta Andover facility in the field of AAV therapeutic release and stability. The individual will perform Replication Competent Adeno-associated virus (rcAAV) Detection assay using Quantitative Polymerase Chain Reaction, qPCR as endpoint readout of release and stability samples for early/late phase clinical and commercial AAV therapeutic products. This individual may assist in troubleshooting rcAAV assays being conducted in Andover, MA and at contract testing laboratories. All aspects of this position involve working in a GMP compliant manner. The individual will lead a team engaged in conducting rcAAV assays in support of release and stability of commercial AAV therapeutic products. This individual will also be responsible for supervising and training 1-3 junior QC associates as well management of their performance.
Primary Responsibilities Include:
- Perform testing of release and stability samples for early and late phase clinical and commercial lots by Replication Competent AAV (rcAAV) and Quantitative Polymerase Chain Reaction, qPCR.
- Hands on experience of maintenance, media preparation and cryopreservation of unique mammalian and recombinant cell lines for cell-based assays is preferred
- Manage activities related to cell banking and managing cell supplies at Andover or external testing sites.
- Experience in general laboratory experimentation and documentation with adherence to cGMP is necessary
- Perform other related duties incidental to the work described
Desired Education and Skills:
- B.S. or M.S. degree in molecular biology or cell biology
- QC Associate I/II: 0 – 2 years relevant experience
- Sr. QC Associate: 2 – 5 years relevant experience
- Working experience in a cGMP environment is preferred.
- A strong understanding of viral transduction vectors in mammalian cells, genomic DNA purification, cell culture, qPCR, Thermocyclers, working in biological safety cabinets (BSC) and PCR enclosures is required
- Experience in general laboratory experimentation, documentation (GDP) with adherence to cGMP is desirable
- Attention to details is a must
- Strong organizational skills, maintaining excellent laboratory records
- Effective written and verbal communication skills
This position requires work on site at one of Sarepta’s facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.