Solid Biosciences, Inc. (Charlestown, MA) seeks Principal Associate Scientist, Analytical Development as follows: Job Description: 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. Job Requirements: 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. Salary: $110,000.00
Originally posted by Solid Biosciences. View original posting
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