Director Biotech Production

Regeneron Pharmaceuticals•Saratoga Springs, NY

8d•Onsite

About The Position

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 startup 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

Bachelor's in a physical or biological science or chemical engineering and 12+ years of biopharmaceutical/biotech work in a GMP production facility
8-10 years (MA/MS), or 4-7 years (PhD) of biopharmaceutical/biotech work in a GMP production facility
Demonstrated experience leading operational start-up for a clinical and commercial biologics manufacturing facility
Experience working with industrial systems such as SCADA, DCS, MES, and PAT technologies
Requires regular presence on the production floor and entry into classified/controlled environments requiring gowning

Nice To Haves

Experience implementing industrial systems (SCADA, DCS, MES, PAT) from an operational perspective is preferred
Familiarity with other Industry 4.0 technologies and strategies is a plus

Responsibilities

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 2,000L and 10,000L 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
Takes accountability for team performance and results from day one