Associate Director, Drug Substance Manufacturing & Development
Skills
- Extensive small molecule process development and cGMP manufacturing experience.
- Proven track record managing CDMOs and external suppliers.
- Strong knowledge of ICH Q7 and phase-appropriate control strategies.
- Experience with solid-state characterization and polymorph/salt selection.
- Ability to author and review regulatory and technical CMC documents.
- Strong cross-functional collaboration, troubleshooting, and project management skills.
Responsibilities
- Serve as subject matter expert for drug substance process design, controls, and characterization.
- Manage development and manufacturing activities with external drug substance CDMOs.
- Lead route selection, process optimization, scale-up and technology transfer for small molecule drug substances.
- Identify critical process parameters and critical quality attributes and define acceptance criteria.
- Review and approve vendor documentation including protocols, reports, raw data, and batch records.
- Perform impurities fate analysis and develop end-to-end control strategies.
- Lead solid-state evaluation (polymorph/salt/co-crystal) and support formulation and IP protection.
- Support quality investigations, CAPAs, change control, and deviation management for internal and external operations.
- Author, review, and approve CMC documentation in support of IND/NDA and other global regulatory filings.
- Provide technical guidance to internal CMC and discovery teams and conduct on-site supplier support and audits as needed.
Education
- Bachelor’s or Master’s degree in Organic Chemistry with 12+ years’ relevant experience
- Or PhD in Organic Chemistry with 8+ years’ relevant experience
Benefits
- Competitive base salary plus target bonus (20%)
- Stock options / equity
- Health, dental, life, and disability insurance
- Generous paid time off and paid holidays
- 401(k) plan
- Commuter / parking benefits (for on-site locations)
- Opportunities for career growth in a publicly traded biotech
Average salary estimate
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