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About the Role
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.
Responsibilities
- Evaluating and establishing viral control strategy and implementing remediation efforts where necessary.
- Reviewing procedures and protocols for viral detection, containment and decontamination.
- Interfacing with Regulatory Authorities and maintaining an up-to-date awareness of regulatory issues related to viral control.
- Owning scientific oversight for virology program and reporting to management.
- Developing a broad understanding of virological subtleties with respect to biotechnological processes and staying current with technical and professional literature.
- Developing and approving test protocols.
- Approving & performing investigations and remediation plans.
- Playing an integral part in investigating and troubleshooting equipment, testing and process abnormalities related to virology.
- Leading investigations related to virological abnormalities.
- Participating in laboratory investigations to ensure effective root-cause analysis and corrective action plans determination.
Requirements
- PhD in virology or related field preferred; relevant experience in biopharmaceutical virology may be substituted for an advanced degree.
- Minimum 10 years in GMP biopharmaceutical/pharmaceutical environment.
- Experience participating in regulatory inspections, presenting/defending positions in audits or regulatory inspections.
Location
- Rensselaer, New York, United States
Work Type
- On-site
Experience Level
- Associate Director
- Level will be determined based on experience and qualifications.
Education Level
- PhD in virology or related field preferred
- Relevant experience in biopharmaceutical virology may be substituted for an advanced degree.
Salary/Compensations
- $147,800.00 - $241,200.00
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 committed to building a workplace with an inclusive culture.
- Regeneron believes we do our best work when we are together.
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.