Solid Biosciences is looking to hire a Scientist, Analytical Development to be responsible for analytical development, qualification 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:
- Providing technical expertise on different aspects of analytical development, including identifying new technology, identifying and assessing Quality Product Attributes, assessing process-related and product-related impurities and executing methods for characterization of final drug product
- Lab operation: perform and coordinate analytical testing in support of process development, cGMP investigations and product characterization
- Analytical Development: support the development of new methods by identifying, evaluating and executing analytical methods to support ongoing analytical needs
- GMP manufacturing: participate in the support of analytical activities at CMOs and CTOs related to analytics including method qualification, datatrending, troubleshooting, optimization, review and reporting
- Management of external resources: assist in the execution of analytical development activities at CTOs and CMOs, including deliverables and timelines
- Technology Transfer: Participate in tech transfer of intellectual property, 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:
- Bachelor degree in Molecular Biology, Biology, Genetics or related field and 8+years’ experience in analytical development within a biotech/pharmaceutical analytical development and/or Quality Control environment required or Ph.D. inMolecular Biology, Biology, Genetics or related field and 2+ years of experience or Masters’ degree and 6+ years’ experience
- In-depth understanding of analytical methods including: cell culture, qPCR, ELISA, flow cytometry and potency assays.
- Experience working in cGMP supporting analytical development/Quality Control environment with an understanding of regulatory requirements and trends related to product quality
- Good understanding of compliance and cGMP considerations.