Senior Principal Scientist, Drug Substance
Ladders · United States · 1 wk ago
RemoteRemoteAnalyst$175k–$230k/yrFull-time
Responsibilities
- Lead end-to-end drug substance process development and manufacturing for small molecule APIs
- Serve as primary technical interface with CDMOs for oversight and troubleshooting
- Lead drug substance process validation from protocol development to batch execution
- Author and review CMC sections for regulatory submissions and represent CMC in agency interactions
- Partner with drug product development and analytical teams to align on technical requirements
- Manage drug substance change control strategy for CDMO manufacturing changes
- Ensure compliance with GMP and readiness for inspections and submissions
Qualifications
- Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or related discipline
- 12+ years of experience in drug substance process development and manufacturing
- Hands-on expertise in small molecule API process development including impurity profiling
- Proven experience managing CDMOs for development and commercialization phases
- Demonstrated ability to author regulatory submissions and engage with regulatory agencies
- Deep knowledge of ICH guidelines relevant to drug substances
- Ability to thrive in fast-paced startup environments
Benefits
- Full-coverage health insurance for you and dependents
- $1,000 home office equipment stipend
- Annual $1,200 learning budget for professional development
- Monthly wellness budget of $250 for various well-being needs
- Extended weekends with 3-day weekends turned into 4-day ones
- Unlimited vacation and paid holidays
- Paw-ternity leave for pet adoption
- Competitive salary package
- Equity options for new hires