Overview
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.
Responsibilities
Lead a team of program managers executing biologics and CGT programs, driving timeline acceleration and optimization across internal and external manufacturing capacity, regulatory milestones, and resource constraints.
Collaborate 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 groups.
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 such as label extensions, process optimization, and global expansion projects.
Implement governance systems, KPIs, and escalation processes that ensure proactive risk management and portfolio control.
Qualifications
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 Bachelor's degree, with 18+ years of experience in biologics or cell & gene therapy operations with a proven record advancing products through clinical and commercial stages, or an equivalent combination of education and experience. PhD or MS in Molecular Biology, Biochemistry, Bioengineering or related biological sciences preferred.
Additional Information Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter.
Please be advised that Regeneron requires on-site work for many roles. Please speak with your recruiter and hiring manager for more information about on-site policy and expectations for your role and location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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.
For roles based in the U.S., salary ranges are shown in accordance with U.S. law and apply to U.S.-based positions. For roles based in Japan and/or Canada, ranges are shown according to local law and currency. If you are outside the U.S, Japan, or Canada, please speak with your recruiter about salaries and benefits in your location.
Some background checks will form part of the recruitment process and will be conducted in accordance with applicable law. The purpose is to verify information such as identity, right to work, and educational qualifications prior to employment.
Salary Range (annually) $239,600.00 - $399,400.00
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Responsibilities
Lead a team of program managers executing biologics and CGT programs, driving timeline acceleration and optimization across internal and external manufacturing capacity, regulatory milestones, and resource constraints.
Collaborate 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 groups.
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 such as label extensions, process optimization, and global expansion projects.
Implement governance systems, KPIs, and escalation processes that ensure proactive risk management and portfolio control.
Qualifications
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 Bachelor's degree, with 18+ years of experience in biologics or cell & gene therapy operations with a proven record advancing products through clinical and commercial stages, or an equivalent combination of education and experience. PhD or MS in Molecular Biology, Biochemistry, Bioengineering or related biological sciences preferred.
Additional Information Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter.
Please be advised that Regeneron requires on-site work for many roles. Please speak with your recruiter and hiring manager for more information about on-site policy and expectations for your role and location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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.
For roles based in the U.S., salary ranges are shown in accordance with U.S. law and apply to U.S.-based positions. For roles based in Japan and/or Canada, ranges are shown according to local law and currency. If you are outside the U.S, Japan, or Canada, please speak with your recruiter about salaries and benefits in your location.
Some background checks will form part of the recruitment process and will be conducted in accordance with applicable law. The purpose is to verify information such as identity, right to work, and educational qualifications prior to employment.
Salary Range (annually) $239,600.00 - $399,400.00
#J-18808-Ljbffr