Sr. Director, Chemical Development
Remote
Job Summary
Oversee chemical development strategies and activities for small molecule programs, leading route scouting, selection, and process optimization to improve yield, purity, and scalability. Manage CDMO process chemistry teams from candidate selection through NDA approval, executing detailed development and manufacturing work plans with active technical oversight. Develop impurity control strategies, including mutagenic and nitrosamine risk management, while leading scale-up, crystallization, isolation, and GMP manufacturing activities. Author regulatory documents, approve batch records and change controls, and interact with health authorities for IND/NDA submissions. Collaborate with cross-functional teams to address supply challenges and manage budgets, timelines, and resources for multiple programs in a clinical-stage biopharmaceutical environment.
Required Qualifications
- Leadership role experience
- Internal and external CMC activities experience
- Small molecule programs experience
- Synthetic route selection and optimization experience
- Process development experience
- Impurity control experience
- Scale-up experience
- Technology transfer experience
- GMP drug substance manufacturing experience
- CDMO experience
- Early development through late-stage development experience
- Commercialization experience
- Strong scientific judgment
- Hands-on execution
- Experience interacting with regulatory authorities
- IND/NDA submissions support experience
- Chemical development strategies and activities oversight experience
- Complex technical and supply challenges resolution experience
- Senior leadership collaboration experience
- Research, Regulatory, Quality Assurance, Drug Product, Supply Chain, and Clinical Operations collaboration experience
- Chemical development risks and timeline impacts communication experience
- CDMO process chemistry teams leadership experience
- Candidate selection through NDA approval and launch leadership experience
- Route scouting experience
- Route selection experience
- Process optimization experience
- Safety, robustness, yield, purity, scalability, cost, and raw material availability improvement experience
- Phase-appropriate impurity control strategies development experience
- Impurity formation understanding experience
- Impurity fate understanding experience
- Impurity purge understanding experience
- Impurity carryover understanding experience
- Mutagenic impurity risk understanding experience
- Nitrosamine risk understanding experience
- Process scale-up experience
- Crystallization and isolation development experience
- Technology transfer experience
- Process characterization experience
- Validation experience
- GMP manufacturing activities experience
- Detailed development and manufacturing work plans design and execution experience
- CDMO active technical oversight experience
- Partner accountability for quality, timelines, budgets, and deliverables experience
- Regulatory documents authoring and approval experience
- Development reports authoring and approval experience
- Manufacturing documentation authoring and approval experience
- Health authority questions response experience
- Regulatory interactions participation experience
- Protocols review and approval experience
- Reports review and approval experience
- Batch records review and approval experience
- Deviations review and approval experience
- Investigations review and approval experience
- Change controls review and approval experience
- Corrective and preventive actions review and approval experience
- Budgets development experience
- Timelines development experience
- Resource plans development experience
- Internal scientists management and mentorship experience
- Consultants management and mentorship experience
- External technical teams management and mentorship experience
- Culture of urgency, ownership, and collaboration fostering experience
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