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About the Role

This role leads manufacturing readiness for facility start-up, spanning staffing, training, equipment commissioning, and operational readiness. It involves setting operating standards for a new biologics drug substance facility and connecting floor-level work to global IOPS goals.

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

Requirements

• Bachelor's in a physical or biological science or chemical engineering
• 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
• Experience implementing SCADA, DCS, MES, and PAT technologies from an operational perspective is preferred
• Requires regular presence on the production floor and entry into classified/controlled environments requiring gowning

Skills

• Familiarity with other Industry 4.0 technologies and strategies is a plus

Location

• Saratoga Springs, New York, United States

Work Type

• On-site
• Full-time

Experience Level

• Director

Education Level

• Bachelor's degree
• Master's degree
• PhD

Salary/Compensations

• $172,200.00 - $286,900.00

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

About the Company

• Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
• Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.
• Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.
• Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Equal Opportunity

• 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.