Regeneron
Executive Director, CMC Program Management (Biology)
Regeneron, Troy, New York, United States
Executive Director, CMC Program Management (Biology)
We are hiring an Executive Director to lead operations and program management for a diverse portfolio of biology-based advanced therapies (AAV, CGT, protein biologics, viral vectors). Oversees cross‑functional execution from early development through commercialization, ensuring timely supply, regulatory readiness, and strategic coordination across all technical and operational interfaces.
In this role, a typical day might include the following:
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.
This role might be for you if you have:
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.
To be considered for this role you must hold a Bachelors degree, with 18+ years of experience in biologics or cell & gene therapy operations with proven record advancing products through clinical and commercial stages, or equivalent combination of education and experience. PhD or MS in Molecular Biology, Biochemistry, Bioengineering or related biological sciences preferred.
Salary Range (annually) $239,600.00 - $399,400.00
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
#J-18808-Ljbffr
In this role, a typical day might include the following:
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.
This role might be for you if you have:
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.
To be considered for this role you must hold a Bachelors degree, with 18+ years of experience in biologics or cell & gene therapy operations with proven record advancing products through clinical and commercial stages, or equivalent combination of education and experience. PhD or MS in Molecular Biology, Biochemistry, Bioengineering or related biological sciences preferred.
Salary Range (annually) $239,600.00 - $399,400.00
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
#J-18808-Ljbffr