Principal Associate Scientist

Principal Associate Scientist

5 days ago Requisition

Salary: $ Annually

Solid Biosciences, Inc. (Charlestown, MA) seeks Principal Associate Scientist, Analytical Development as follows:

• Summary:
  
  Responsible for analytical development, qualification and operational support for Preclinical, Phase 1 and Phase 3 of clinical products.
• Support the development and execution of analytical methods directly related to process development cGMP manufacturing of Solid Biosciences leading candidate.
• Lab operation: routine and non-routine analytical testing, coordination with internal/external PD or cGMP Manufacturing, critical reagent qualification, maintain laboratory equipment, maintain laboratory inventory, compile and present data to support process development and stability.
• 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 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.
• Act as subject matter expert and involved in updates to Operational and Senior Management teams.
• May have responsibility for management and mentorship of junior scientists.
• Technology Transfer:
  Participate in tech transfer of analytical methods, protocols/procedures and know-how from internal labs to CMOs/CTOs, or between CMOs/CTOs.
• Contribute towards assay qualification at CMOs/CROs.
• Travel required 10% of the time, domestic only.

• Master’s of Science in Biotechnology, Microbiology, Biology, Genetics or related field (or foreign equivalent).
• Two (2) years of experience in analytical development or quality control within a biotech/pharmaceutical process development or manufacturing environment.
• One (1) year of experience with molecular and cell based analytical methods including cell culture, In vitro cell based assays, ddPCR, qPCR, ELISA.
• One (1) year of experience working in cGMP supporting analytical development/Quality control environment with an understanding of regulatory requirements and trends related to product quality.
• One (1) year of experience with Electronic Lab Notebook (ELN).
• One (1) year of experience with compliance and cGMP considerations.