Scientist Group Leader
Core
Lead the design, development, and execution of analytical methods for active pharmaceutical ingredients (APIs) including traditional synthetic molecules and peptides.
Role type
Senior IC analytical scientist (API development)
Builds
Analytical procedures and specifications for API development and manufacture
Domain
Pharmaceutical industry, analytical chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC/UPLC, GC, IC, LC-MS, GC-MS, NMR, ICP-MS, FTIR, UV-Vis, particle size analysis, water content analysis, method qualification, validation, GMP compliance, regulatory audit participation
Preferred skills
Leadership experience, Process Development of APIs
Technologies
HPLC, UPLC, GC, IC, LC-MS, GC-MS, NMR, ICP-MS, FTIR, UV-Vis, XRPD, KF
Responsibilities
Lead design and execution of phase-appropriate analytical methods in compliance with ICH and Health Authority guidelines; Perform release and stability testing on starting materials, intermediates, and APIs; Author and review technical documents including method qualification/validation/transfer protocols; Maintain and troubleshoot analytical instrumentation; Contribute to audit readiness and participate in quality audits with FDA and other Regulatory Agencies; Ensure work compliance with state and federal regulations including GMP and DEA
Seniority
Senior, hands-on IC
