Executive Director, Chemical Process R&D
About The Position
The Executive Director, Chemical Process R&D owns drug substance (DS) process strategy and execution oversight, ensuring synthetic routes, starting-material strategy, impurity understanding, and process controls support scalable, safe, and cost-effective external manufacturing. The role leads organic chemistry resources to develop process understanding, robust operating ranges, and technology-transfer packages for contract development and manufacturing organizations (CDMOs). It partners with Analytical Development and Engineering to align analytical method readiness, process safety, and validation expectations, and ensures DS contributions to CMC documentation are clear and regulator ready.
Requirements
- BS or higher in Chemistry or a related field.
- 18+ years of process chemistry or DS development experience with external manufacturing support.
- Demonstrated leadership of route development, impurity strategy, and technology transfer.
- Strong technical writing and cross-functional leadership.
- Synthetic/process chemistry leadership and impurity/control strategy expertise.
- Experience with technology transfer and CDMO governance.
- Risk assessment, troubleshooting, and decision-framing skills.
- Ability to provide high-quality CMC documentation inputs.
Nice To Haves
- PhD in Chemistry or a related field.
- Experience developing starting-material strategies and supporting Phase 2 progression.
- Experience supporting polymorph or solid-form implications for the DS/DP interface.
Responsibilities
- Define DS route and starting-material strategy aligned with a phase-appropriate control strategy.
- Approve process R&D plans for optimization, robustness, and impurity investigations.
- Ensure DS deliverables support clinical supply builds and lifecycle readiness.
- Lead DS technology-transfer expectations and readiness criteria for CDMOs.
- Provide technical oversight for deviations, investigations, CAPA, and change impacts.
- Drive continuous-improvement initiatives involving yield, cycle time, and robustness.
- Partner with Analytical on method needs for process characterization and control strategy.
- Partner with Engineering on scale-up, safety, and equipment and process suitability.
- Provide DS inputs and rationales for CMC documents and health authority responses.
- Lead organic chemistry resources to generate process understanding, robust operating ranges, and technology-transfer packages.
Benefits
- Equity for employees.
- Flexible paid time off.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- Life and disability insurance.
- 401(k) offerings, including traditional and Roth options and employer match.
- Supplemental life insurance.
- Legal services.
- Mental health benefits through the Employee Assistance Program for employees and their family.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
