Director or Senior Director, API Development
Skills
- Deep experience in small-molecule medicinal chemistry and API development
- CDMO selection, transfer, and relationship management
- IND-enabling development and regulatory submission authoring
- Analytical techniques: LC, GC, NMR, MS, XRPD
- Knowledge of FDA, EU, and ICH guidelines for drug substance manufacturing
- Process development, optimization, and scale-up
- Technical writing and documentation for regulatory compliance
- Proficiency with ChemDraw and MS Office (Word, Excel, PowerPoint)
- Strong leadership, communication, and cross-functional collaboration
- Troubleshooting and root-cause analysis
Responsibilities
- Lead selection, transfer, and management of CDMO manufacturing activities
- Oversee current drug substance manufacturing and continuous process improvement
- Troubleshoot CDMO manufacturing issues and non-conformities
- Identify and resolve regulatory compliance gaps for drug substance manufacturing
- Support formulation development with API optimization and impurity identification
- Author and review IND-enabling protocols, reports, and regulatory submissions
- Develop synthetic routes for new entities and advance process development
- Conduct intellectual property assessments and support IP generation
- Manage documentation, project planning, and cross-functional communication
Education
- PhD, Master's, or Bachelor's degree in chemistry, chemical engineering, biomanufacturing, or related physical science
Benefits
- Anticipated base pay range $220,000 - $240,000 (DOE)
- Annual performance incentive bonus
- New hire equity package
- Medical, dental, and vision insurance
- 401(k) match
- Paid time off and paid holidays
- Remote work arrangement
- Equal opportunity employer and competitive total compensation
Average salary estimate
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