Executive Director, CMC Program Management (Chemistry)
Regeneron
Full-time
On-site
Troy, NY
Operations
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Role Summary
Executive Director to lead program management for a portfolio of chemistry-based advanced therapies. Responsible for end-to-end operational coordination—linking Manufacturing, R&D, CMC, clinical, regulatory—to enable accelerated development and commercialization of advanced therapy treatments.
Responsibilities
- Lead and develop a team of 6–10 program managers overseeing 20–30 active programs across clinical and commercial stages.
- Drive timeline acceleration and optimization, balancing priorities across internal and external manufacturing capacity, regulatory milestones, and resource constraints.
- Work closely with clinical, development and manufacturing teams to proactively identify and resolve development and supply bottlenecks impacting clinical, regulatory or commercial deliverables.
- Oversee clinical and commercial launch supply readiness through coordination with internal teams and external manufacturing group.
- Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages.
- Collaborate with Finance to inform investment needs and help secure program budgets in a timely manner.
- Provide program management leadership for tech transfers, manufacturing readiness, and process scale-up.
- Coordinate post-launch activities including lifecycle expansions, process improvements, and indication growth.
- Establish governance tools, dashboards, and metrics for portfolio visibility and decision-making.
Qualifications
- Required: Bachelors degree, with 18+ years of experience in Biopharma Operations, CMC, or Program Management with direct experience in ADC, siRNA, or mRNA product development and successful launches, or equivalent combination of education and experience.
- Preferred: Ph.D. or M.S. in Chemistry, Biochemistry, Chemical Engineering, or Pharmaceutical Sciences.
Skills
- Demonstrated success managing cross-functional timelines under complex capacity, regulatory, and technical constraints.
- Strong understanding of process chemistry, analytical development, conjugation technologies, and tech transfer.
- Proven ability to partner with scientists and engineers to drive efficient execution and innovation.