Head of Virology
Regeneron Pharmaceuticals
Summary
Regeneron is seeking a Sr. level technical leader of Virology to run the viral safety program for our bulk biopharmaceutical manufacturing facility. You will assess the current state of our program, build a robust, phase-appropriate strategy grounded in industry best practices and evolving regulatory expectations, and drive improvements that protect our patients, our products, and our supply. You will also serve as the senior management advisor and the go-to scientific authority on all virology-related matters.
Job description
When & Where
- Monday-Friday, 8:00am-4:30pm
- Location: Rensselaer, New York, United States
Discover your role
- Define, own, and continuously evolve the site's viral control strategy, including risk assessments and remediation efforts where needed.
- Provide executive-level scientific direction and serve as the primary advisor to senior leadership on virology-related risk, strategy, and decision-making.
- Own scientific oversight of the virology program and the management reporting that goes with it.
- Review and approve procedures and protocols for viral detection, containment, and decontamination, ensuring cGMP compliance.
- Serve as the company's voice on virology with Regulatory Authorities: represent the program in inspections and audits, defend scientific positions, and stay ahead of emerging regulatory expectations on viral safety.
- Develop and approve test protocols, investigation plans, and remediation plans.
- Lead investigations into virological abnormalities and ensure rigorous root-cause analysis and effective corrective and preventive action (CAPA).
- Partner with Manufacturing, Quality, Process Development, and Technical Operations to troubleshoot equipment, testing, and process abnormalities related to virology.
- Stay at the forefront of virology science, biotechnology processes, and industry literature, and bring that knowledge into program strategy.
- Build, mentor, and develop a high-performing virology team, and set the vision and priorities for the function.
This role requires
- PhD in virology or a related field preferred. Direct relevant experience in biopharmaceutical virology may be considered in lieu of an advanced degree.
- Minimum 12 years of experience in a GMP biopharmaceutical or pharmaceutical environment, with a demonstrated record of increasing scope and leadership responsibility in viral safety.
- Proven experience leading and presenting/defending positions during regulatory inspections and audits.
- Demonstrated ability to influence and advise senior leadership and to lead through cross-functional collaboration.
- Experience building or leading teams and managing people is strongly preferred.
Requirements
- PhD in virology or a related field preferred; direct relevant experience may be considered in lieu of an advanced degree
- Minimum 12 years of experience in a GMP biopharmaceutical or pharmaceutical environment
- Demonstrated record of increasing scope and leadership responsibility in viral safety
- Proven experience leading and presenting/defending positions during regulatory inspections and audits
- Demonstrated ability to influence and advise senior leadership
- Ability to lead through cross-functional collaboration
- Experience building or leading teams and managing people strongly preferred
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.