Sr Associate Scientist, FPD
Core
Develop small molecule drug formulations and manufacturing processes from pre-exploratory stages through commercialization, supporting drug candidate selection and scale-up.
Role type
Senior Associate Scientist, Small Molecule Formulation and Process Development
Builds
Clinical and development drug product batches, optimized manufacturing processes, and regulatory filings (IND to NDA)
Domain
Pharmaceutical manufacturing, small molecule drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug substance and drug product characterization, GMP documentation, laboratory instrumentation operation, experimental design, process optimization, technical reporting, risk assessment
Preferred skills
Subject matter expertise on specific equipment, training less experienced colleagues, cross-functional collaboration
Technologies
Electronic lab notebook, GMP documentation systems
Responsibilities
Operate laboratory instrumentation and processing equipment; design and execute moderately complex experiments; troubleshoot analytical methods and manufacturing processes; develop and optimize manufacturing processes; oversee manufacture of GMP clinical and development drug product batches; author technical reports and regulatory submissions; maintain laboratory functions and compliance with EHS policies
Seniority
Mid-Senior level, hands-on IC with mentorship responsibilities