Solid Biosciences is looking to hire an Associate Scientist, Analytical Development to be responsible for analytical routine testing and operational support for Preclinical, Phase 1 and Phase 3 of clinical products for Solid Biosciences. Solid Biosciences’ leading candidate is an adeno-associates virus (AAV) based gene therapy product for the treatment of Duchenne Muscular Dystrophy (DMD).
Key Duties & Accountabilities:
- Execute experiments in support of ELISA, and other relevant biological analytic method development and optimization, with guidance
- Internal/external PD or cGMP Manufacturing, maintain laboratory equipment, maintain laboratory inventory, compile and present data to support process development and stability
- GMP manufacturing: participate in the support of manufacturing activities at CMOs and CTOs related to analytics including coordinating testing, shipments, inventory, data review and reporting
- Maintain well documented records of analytical data, laboratory notebooks, execution of assays and stability data
- Technology Transfer: Participate in tech transfer of analytical methods, protocols/procedures and know-how from internal labs to CMOs/CTOs, or between CMOs/CTOs. Performs other related duties and ad hoc projects as required by position.
Education, Experience & Skills:
- B.S. in Microbiology, Biology, Genetics or related field; no experience required
- Working knowledge of ELISA, biological cell-based assays, and/or PCR-based assays
- The ability to learn different methods quickly with exceptional accuracy and technique
- Gene Therapy experience desired, but not required
- Experience working in cGMP supporting analytical development/Quality Control environment with an understanding of regulatory requirements and trends related to product quality desired, but not required
- Understanding of compliance and cGMP considerations