Director Biotech Production
About The Position
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 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 SCADA, DCS, MES, and PAT systems 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
Benefits
- 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
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Director
