Principal Research Scientist II, Process Chemistry
Core
Lead drug substance process development and characterization for small molecule clinical candidates, translating lab processes to scalable cGMP manufacturing.
Role type
Principal Research Scientist II (Process Chemistry)
Builds
Scalable drug substance processes for clinical candidates
Domain
Pharmaceutical process chemistry (small molecules)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Organic chemistry, mechanistic theory, process development, control strategy development, regulatory starting material strategies, GMP manufacturing, mentoring scientific leaders
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead project teams for drug substance process development and characterization; Develop and characterize drug substance processes in the laboratory and translate them to scalable processes; Mentor staff in troubleshooting strategic and experimental issues; Author and review key regulatory documents, laboratory data, technical memos and reports
Seniority
Principal, hands-on IC with strategic leadership