Director Biotech Production

Director, Biotech Production

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.

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 2,000L 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

This role requires:

• Bachelor's in a physical or biological science or chemical engineering and 12+ years of biopharmaceutical/biotech work in a GMP production facility with 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; experience implementing these systems from an operational perspective is preferred
• Familiarity with other Industry 4.0 technologies and strategies is a plus
• Gowning and
  
  Physical Requirements:
  
  requires regular presence on the production floor and entry into classified/controlled environments requiring gowning

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.

The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. 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  For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Salary Range (annually): $ - $