From Regeneron Pharmaceuticals's posting. “We” and “our” refer to the employer.
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.
In this role, you will provide technical leadership across equipment characterization, cycle development, tech transfer, and troubleshooting for our aseptic fill/finish value stream, while collaborating with Quality, Engineering, Automation, and Validation to keep our fill/finish equipment and processes in a state of control.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
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? Apply now to take your first step towards living the Regeneron Way! 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. If you have any questions, please speak with your recruiter.
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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
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.
Compensation
Salary Range (annually)
$172,200.00 - $338,400.00
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