Senior Scientist, Process Development
Core
Developing chemical processes for the manufacturing of drug substances to support clinical studies and commercialization.
Role type
Senior Scientist, Process Development (IC with team management)
Builds
Drug substances for HIV, viral hepatitis, COVID-19, and cancer therapies
Domain
Pharmaceutical manufacturing / Organic Chemistry
Required skills
multi-step organic synthesis, process scale-up, safe process development, purification techniques, analytical techniques (HPLC, LCMS, NMR), project strategy, team management, technical documentation (MBRs), cGMP compliance, SOP adherence
Preferred skills
pilot plant operations, process validation, regulatory filings, project and people management
Technologies
HPLC, LCMS, NMR, Master Batch Records (MBRs)
Responsibilities
Develop chemical processes for drug substance manufacturing; Plan and execute laboratory experimentation to advance production knowledge; Propose alternative chemistry and route optimization; Manage project team members and research assignments; Prepare and review technical documents including Master Batch Records; Collaborate with analytical chemistry, QA, and manufacturing teams; Provide technical support for cGMP laboratory and large-scale manufacturing operations
Seniority
Senior, hands-on IC with team management
