Senior Scientist, Analytical CMC
$154,000–$185,850 year
On-siteMillbrae, California, United States
Job Summary
Lead analytical strategy for drug substance and drug product programs from IND-enabling studies through commercial readiness, coordinating activities with CMC, Quality, Regulatory, and external CRO/CDMO partners. Support method development, troubleshooting, qualification, transfer, and validation for drug product, intermediates, and raw materials while providing hands-on laboratory support for non-GMP sample analysis, CoA creation, and stability testing. Provide scientific oversight of CRO/CDMO deliverables, including review of methods, protocols, and investigations, and contribute to control strategies, specifications, and regulatory submission content. Proactively identify risks, propose mitigation strategies, and communicate technical guidance to cross-functional stakeholders and junior staff.
Required Qualifications
- Degree in analytical chemistry, chemistry, pharmaceutical sciences, or a related discipline
- 5+ years of experience for Ph.D. candidates
- 14+ years of experience for M.S. candidates
- 16+ years of experience for B.S. candidates
- Directly relevant experience in analytical development
- Directly relevant experience in CMC analytical support for clinical and/or commercialization stages
- 5–6+ years of directly relevant experience for M.S.-level candidates
- 10+ years of directly relevant experience for B.S.-level candidates
- Experience supporting DS and/or DP analytical development from clinical through registration
- Working knowledge of key analytical techniques, including HPLC/UPLC, dissolution, GC, LC-MS, KF, spectroscopy, solid-state, and compendial methods
- Hands-on experience with method development, troubleshooting, qualification, transfer, and/or validation in pharmaceutical or regulated lab settings
- Understanding of phase-appropriate CMC, GMP/non-GMP, quality, and regulatory expectations for methods, validation, impurities, stability, shelf-life, and specifications
- Strong communication, collaboration, organization, and problem-solving skills
- Ability to manage priorities and explain scientific rationale clearly
Desired Qualifications
- Experience representing analytical development on cross-functional CMC teams from IND-enabling through later-stage development
- Experience with analytical control strategy, specifications, stability, shelf-life, trending, or regulatory submission content
- Experience overseeing CRO/CDMO or external lab activities
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.