Regeneron · 2 weeks ago
Executive Director, CMC Program Management (Biology)
Troy, NY
Full-time
Onsite
Director/Executive
$240K/yr - $399K/yr
18+ years expRegeneron is hiring an Executive Director to lead operations and program management for a diverse portfolio of biology-based advanced therapies. The role involves overseeing cross-functional execution from early development through commercialization, ensuring timely supply and regulatory readiness.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Lead a team of 6–10 program managers executing 20–30 biologics and CGT programs
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
Support post-commercial initiatives—label extensions, process optimization, and global expansion projects
Implement governance systems, KPIs, and escalation processes that ensure proactive risk management and portfolio control
Qualification
Required
Bachelors degree
18+ years of experience in biologics or cell & gene therapy operations
Proven record advancing products through clinical and commercial stages
Deep understanding of vector biology, cell culture, purification, and analytical control strategies
Demonstrated expertise in program management, regulatory coordination, and cross-functional execution under complex operational constraints
Strong communicator who effectively bridges science, manufacturing, and business priorities
Preferred
PhD or MS in Molecular Biology, Biochemistry, Bioengineering or related biological sciences
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase