Senior Scientist, Analytical Development

Role: Senior Scientist in Analytical Development supporting early and late-stage biopharmaceutical projects. Responsibilities: develop, validate, transfer, and troubleshoot analytical methods (e.g., HPLC, LC/MS, GC/MS) for API, drug substances, and formulations; oversee analytical test development at CROs/CMOs; prepare documentation for regulatory submissions (INDs, NDAs, MAAs); perform impurity investigations; support stability studies and provide analytical expertise across discovery and development phases. Qualifications: Master's (5+ years) or PhD (4+ years) in Chemistry, Biochemistry, or Pharmacy; extensive experience in pharmaceutical analytical method development, validation, and troubleshooting; knowledge of GMP, 21CFR, ICH guidelines; proficiency with LIMS, Empower, and electronic lab notebooks; strong communication, organizational, and collaboration skills. Preferred: experience with regulatory writing, authorship of submission sections, responses to health authority inquiries, statistical data analysis, and early-phase formulation analytical methods. High-Value: focus on small molecule APIs and drug products, with involvement across preclinical to late-stage development, including regulatory documentation. Work setup: office/lab based; travel up to 10%.