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Executive Director, CMC Program Management (Biology)

Regeneron

Executive Director, CMC Program Management (Biology)

Regeneron

RENSS - GLOBAL VIEW

·

On-site

·

Full-time

·

1w ago

Compensation

$239,600 - $399,400

Benefits & Perks

Healthcare

401(k)

Equity

Gym

Parental Leave

Paid Time Off

Healthcare

401k

Equity

Gym

Parental Leave

Required Skills

Program management

Regulatory coordination

Cross-functional execution

Vector biology

Cell culture

Purification

Analytical control strategies

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.

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 at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable 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.

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.

Salary Range (annually)

$239,600.00 - $399,400.00

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About Regeneron

Regeneron

Regeneron

Public

Focused on neurotrophic factors and their regenerative capabilities, giving rise to its present name; the company has since expanded operations int...

10,001+

Employees

Westchester County

Headquarters

Reviews

3.2

5 reviews

Work Life Balance

2.0

Compensation

4.3

Culture

2.5

Career

3.5

Management

2.0

Pros

Good pay and benefits

Company events and perks

Great coworkers

Cons

Toxic management

Poor work-life balance

Micromanagement and lack of autonomy

Salary Ranges

1,037 data points

Junior/L3

Junior/L3 · Data Analyst

0 reports

$108,540

total / year

Base

-

Stock

-

Bonus

-

$92,259

$124,821

Interview Experience

5 interviews

Difficulty

2.2

/ 5

Duration

14-28 weeks

Offer Rate

60%

Experience

Positive 80%

Neutral 20%

Negative 0%

Interview Process

1

Application Review

2

Phone/Video Screen

3

Hiring Manager Interview

4

Panel Interview

5

Stakeholder Interview

6

Offer

Common Questions

Technical Knowledge

Behavioral/STAR

Past Experience

Presentation Skills

Culture Fit