Director Biotech Production

Regeneron uses 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.

About the Role

In this on-site role, you will lead manufacturing readiness for facility start-ups 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. You will collaborate closely with Facilities, Process Development, Quality, and Regulatory teams to ensure smooth production operations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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
• Thrives on ownership, taking accountability for team performance and results from day one

Requirements

• Bachelor's in a physical or biological science or chemical engineering
• 12+ years of biopharmaceutical/biotech work in a GMP production facility, with 8-10 years for MA/MS or 4-7 years for PhD
• 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; experience implementing these systems from an operational perspective is preferred
• Familiarity with other Industry 4.0 technologies and strategies is a plus
• Regular presence on the production floor and entry into classified/controlled environments requiring gowning

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
• Family support benefits

Pay

Salary Range (annually): $172,200.00 - $286,900.00

Schedule

• On-site role in Saratoga Springs, New York
• May require off-shift availability and on-call support as part of the manufacturing leadership team