Director Biotech Production

BioSpace • city of saratoga springs, ny, United States • $172.20 - $286.90 / year • 1d ago

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 Director, Biotech Production to join our core manufacturing leadership team, supporting the start‑up of our new biologics drug substance facility in Saratoga Springs, New York in an on‑site role. In this role, you will lead manufacturing readiness for facility start‑up, spanning staffing, training, equipment commissioning, and operational readiness while setting the operating standards for the plant and connecting floor‑level work to global IOPS goals, in close collaboration with Facilities, Process Development, Quality, and Regulatory teams.

When & Where

Location: Saratoga Springs, New York, United States
Work model/flexibility: On‑site
Shift Requirements: May require off‑shift availability and on‑call support as part of the manufacturing leadership team

Discover Your Role

Leads the manufacturing team through facility start‑up, setting the operating standards for a brand‑new biologics plant
Directs manufacturing of recombinant proteins according to approved protocols, regulations, and schedules across 2,000 L and 10,000 L bioreactor suites
Translates corporate objectives into strategy, connecting floor‑level performance to global IOPS goals
Guides validation activities and equipment commissioning/qualification to ensure operational readiness
Partners across Facilities, Process Development, Quality, and Regulatory to keep production running smoothly
Builds and develops a high‑performing team, embracing the ambiguity that comes with standing up a new site
Tracks and trends key metrics to keep operations safe, compliant, and efficient
Thrives on ownership, taking accountability for team performance and results from day one

This Role Requires

Bachelor’s degree in a physical or biochemical or chemical engineering and 12+ years in biopharmaceutical/biotech work in a GMP production facility. Must have 8–10 years with an MA/MS or 4–7 years with a PhD.
Demonstrated experience leading operational start‑up for clinical and commercial biologics manufacturing facilities
Experience with industrial systems such as SCADA, DCS, MES, and PAT technologies; implementation experience preferred
Familiarity with other Industry 4.0 technologies and strategies is a plus
Must wear mandatory gowning and meet physical requirements for routine presence on the production floor and entry into classified/controlled environments

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.

Salary Range (annual): $172,200.00 – $286,900.00

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