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About the Role
Regeneron is seeking a Director of Virology to own and manage an effective viral safety program for a biopharmaceutical manufacturing facility. This role involves assessing the current status, developing a robust program, and implementing improvements based on industry best practices and regulatory concerns. The individual will also serve as a senior management advisor on all virology-related matters.
Responsibilities
- Evaluate and establish viral control strategy and implement remediation efforts.
- Review procedures and protocols for viral detection, containment, and decontamination.
- Interface with Regulatory Authorities and maintain awareness of regulatory issues related to viral control.
- Provide scientific oversight for the virology program and report to management.
- Develop a broad understanding of virological subtleties in biotechnological processes and stay current with literature.
- Develop and approve test protocols.
- Approve and perform investigations and remediation plans.
- Investigate and troubleshoot 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 plan determination.
Requirements
- Minimum 12 years of experience in a GMP biopharmaceutical/pharmaceutical environment.
- Experience participating in regulatory inspections, presenting/defending positions in audits or regulatory inspections.
Skills
- Virology
- Viral safety program management
- Regulatory affairs
- Scientific oversight
- Process improvement
- Root-cause analysis
- Troubleshooting
Location
- Rensselaer, New York, United States
Work Type
- Onsite
Experience Level
- Director
- Senior Management
Education Level
- PhD in virology or related field preferred; relevant experience in biopharmaceutical virology may be substituted.
Salary/Compensations
- $203,000.00 - $338,400.00
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 (medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron is committed to building a workplace with an inclusive culture.
- Regeneron believes in performing best work when together, with many roles required to be performed on-site.
- Background checks may be conducted as part of the recruitment process to verify identity, right to work, and educational qualifications.
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.
- Reasonable accommodation will be provided to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.