Position:  Scientist, Analytical Development
Location:  Cambridge, MA
Job Id:  022
# of Openings:  1

Summary:
 
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.
 
Travel:
  • 0-10%

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