Associate Director Virology

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 148,000 - 241,000; Full time

Job summary

Regeneron is seeking an Associate Director of Virology to own and advance a robust viral safety program for a bulk biopharmaceutical manufacturing facility in Rensselaer, NY. The role requires steering program strategy, ensuring compliance with regulatory expectations, and advising senior management on virology matters.

The position emphasizes technical leadership, implementation of remediation plans, and ongoing improvements in viral control, detection, containment and decontamination

Qualifications

• PhD in virology or related field is preferred; relevant experience may substitute for degree.
• Minimum 10 years in GMP biopharmaceutical environments.
• Experience participating in regulatory inspections or audits.

Responsibilities

• Evaluate and establish viral control strategy and remediation efforts.
• Review procedures for viral detection, containment and decontamination.
• Interface with regulatory authorities and stay updated on regulatory issues.
• Own scientific oversight for the virology program and reporting.
• Develop and approve test protocols; lead investigations and remediation plans.
• Lead root-cause analysis and investigations related to virology.

Skills

Virology

GMP Biopharma

Regulatory interface

Leadership

Education

PhD in Virology or related field

Job description

Regeneron is looking for an Associate Director of Virology This is primarily a technical role responsible for ownership and disposition of an effective viral safety program for a bulk biopharmaceutical manufacturing facility. The individual will assess the current status, develop a robust program and enact improvements based on industry best practices and regulatory concerns. Additionally, this person will act as a senior management advisor for all virology related matters.

When & Where:

Monday-Friday, 8:00am-4:30pm

Location: Rensselaer, New York, United States

Discover your role:

• Responsible for evaluating and establishing viral control strategy and implementing remediation efforts where necessary.
• Responsible for reviewing procedures and protocols for viral detection, containment and decontamination.
• Interface with Regulatory Authorities and maintain an up-to-date awareness of regulatory issues related to viral control.
• Own scientific oversight for virology program and report management.
• Develop a broad understanding of virological subtleties with respect to the biotechnological processes and stay current with technical and professional literature.
• Develop and approve test protocols.
• Approve & perform investigations and remediation plans.
• Play an integral part in investigating and troubleshooting equipment, testing and process abnormalities related to virology.
• Lead investigations related to virological abnormalities.
• Participate in laboratory investigations to ensure effective root-cause analysis and corrective action plans determination.

This role requires:

• PhD in virology or related field preferred; will consider substituting relevant experience in biopharmaceutical virology in lieu of advanced degree.
• Minimum 10 years in GMP biopharmaceutical/pharmaceutical environment.
• Experience participating in regulatory inspections, presenting/defending positions in audits or regulatory inspections.
• Level will be determined based on experience and qualifications.

Does this sound like you?

We are committed to building a workplace with an inclusive culture. 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 necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Salary Range (annually) $147,800.00 - $241,200.00