Sr. Scientist - Pharmacopoeia
Core
Sr. Scientist serving as a technical subject matter expert for compendial analytical methods (USP, EP, JP, ChP) to support drug development and product release.
Role type
Sr. Scientist (Pharmacopoeia/Analytical Methods)
Builds
Testing strategies, specifications, and product release documentation for pharmaceutical clients.
Domain
Life Sciences / Pharmaceutical Quality Control
Required skills
Deep knowledge of major pharmacopeial standards (USP, EP, JP, ChP), method verification and transfer, analytical change controls, risk assessment, technical writing
Preferred skills
Experience with electronic or paper-based QMS, interpreting pharmacopeial monographs
Technologies
USP, EP, JP, ChP, QMS
Responsibilities
Serve as a technical subject matter expert for compendial analytical methods; Evaluate the impact of pharmacopeial revisions on analytical methods and testing strategies; Develop compendial method verification and transfer strategies; Initiate, author, assess, and implement analytical change controls; Support investigations involving atypical results and deviations.
Seniority
Senior, hands-on IC