Analytical Sr Scientist
Core
Develop analytical tools and control strategies for synthetic manufacturing processes and products to support clinical programs from FIH studies through marketing applications.
Role type
Senior Individual Contributor Analytical Scientist (Pharmaceutical/Biotech)
Builds
Analytical methods, control strategies, and technical transfer packages for drug substance and drug product development.
Domain
Pharmaceutical/Biotech, Small Molecule Analysis, Process and Product Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development and validation, Chromatography (HPLC/UPLC), Mass Spectrometry, Solid-state characterization, Regulatory compliance (USP/ICH/FDA/GLP/GMP), Technical transfer management, Cross-functional leadership
Preferred skills
PhD in Analytical/Organic Chemistry/Materials Science/Biochemistry, Experience in immediate/controlled release oral solid dosage forms, Impurity analysis (mutagenic), Technical writing for regulatory filings
Technologies
HPLC, UPLC, Mass Spectrometry, NMR, FTIR, UV
Responsibilities
Integrate platform knowledge to advance analytical practices, Define analytical control strategies for pivotal phase clinical programs, Collaborate with process development teams, Manage activities at contract manufacturing and testing sites, Lead and develop a small group of scientists
Seniority
Senior, hands-on IC with potential for small team leadership
