Senior Director Manufacturing Technical Services

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 172,200 - 338,400; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Medical, dental, vision, life and disb

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Director of Manufacturing Technical Services to support aseptic fill/finish manufacturing for clinical and commercial programs.

Located on-site in Rensselaer, NY, the role leads characterization, troubleshooting, tech transfer, and CAPA across a growing team. The position requires 15+ years in biopharma manufacturing with 8+ years in aseptic fill/finish, plus strong regulatory acumen and experience with major packaging lines and automation systems.

Qualifications

• BS or higher in Engineering/Life Sciences required.
• 10+ years biopharma manufacturing experience; 5+ years in aseptic fill/finish.
• Strong regulatory and quality acumen; able to defend technical positions.

Responsibilities

• Leads technical characterization, cycle development, and troubleshooting for aseptic fill/finish equipment, including filling systems, isolators, stoppering, capping, visual inspection, device assembly, labeling, and packaging.
• Directs tech transfer activities, including clinical and new product introductions, site-to-site transfers, and scale-up/scale-down.
• Owns the visual inspection program, spanning manual inspector qualification/AQL and automated inspection (AVI) systems, including defect library development and camera/algorithm optimization.
• Oversees alarm management and process monitoring strategy, including PAT, continuous monitoring, and alarm rationalization.
• Serves as a key technical resource during regulatory inspections and health authority interactions, authoring and defending technical justifications.
• Owns CAPA and root cause investigations for deviations and complaints tied to fill/finish equipment or process.
• Builds and develops a multi-faceted technical team, growing the maturity of the MTS function over time.
• Communicates technical and equipment risk clearly to senior leadership, translating it into executable steps for manufacturing operations.

Skills

Aseptic fill/finish expertise

Regulatory & quality acumen

Leadership / people management

Education

Bachelor's or higher degree in Engineering, Life Sciences, or related field

Tools

PAS-X

FactoryTalk

PI Vision

GMP instrumentation

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director, Manufacturing Technical Services (MTS) to join our team, supporting our fill/finish clinical and commercial drug product manufacturing operations.

When & where: Location: Rensselaer NY Work model/flexibility: On-site Monday- Friday, 8am-4:30pm

Discover your role:

• Leads technical characterization, cycle development, and troubleshooting for aseptic fill/finish equipment, including filling systems, isolators, stoppering, capping, visual inspection, device assembly, labeling, and packaging.
• Directs tech transfer activities, including clinical and new product introductions, site-to-site transfers, and scale-up/scale-down.
• Owns the visual inspection program, spanning manual inspector qualification/AQL and automated inspection (AVI) systems, including defect library development and camera/algorithm optimization.
• Oversees alarm management and process monitoring strategy, including PAT, continuous monitoring, and alarm rationalization.
• Serves as a key technical resource during regulatory inspections and health authority interactions, authoring and defending technical justifications.
• Owns CAPA and root cause investigations for deviations and complaints tied to fill/finish equipment or process.
• Builds and develops a multi-faceted technical team, growing the maturity of the MTS function over time.
• Communicates technical and equipment risk clearly to senior leadership, translating it into executable steps for manufacturing operations.

This role requires:

• Director Level: Bachelor's or advanced degree in Engineering, Life Sciences, or a related technical field and 10+ years of biopharmaceutical manufacturing experience, including 5+ years in aseptic fill/finish or equivalent combination or education and experience.
• Senior Director Level: Bachelor's or advanced degree in Engineering, Life Sciences, or a related technical field and 15+ years of biopharmaceutical manufacturing experience, including 8+ years in aseptic fill/finish or equivalent combination or education and experience.
• Deep expertise in aseptic fill/finish equipment characterization and troubleshooting for commercial and clinical manufacturing lines.
• Strong regulatory and quality acumen, with the ability to support inspections and defend technical positions to health authorities.
• Platform experience with Bausch+Ströbel (VarioSys, CombiSys), Seidenader Inspection, Harro Hofliger assembly, or Körber (Dividella/Pester) packaging preferred.
• Automation/data historian familiarity (PAS-X, FactoryTalk, PI Vision) preferred.

Does this sound like you?

We are committed to building a workplace with an inclusive culture.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $172,200.00 - $338,400.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.