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We are seeking a Director Virology to lead and own the viral safety program for our bulk biopharmaceutical manufacturing facility. This critical leadership role working with regulatory authorities, maintaining compliance with domestic and international regulations, and driving the effectiveness of viral control strategies. You will play a pivotal role in ensuring the safety and compliance of a cutting-edge biopharmaceutical manufacturing facility. Your expertise will directly impact the success of our operations and the effectiveness of our viral safety program.

As a Director Virology, a typical day might include the following:

+ Developing, implementing, and continuously improving the viral control strategy for the facility

+ Managing virology development laboratory, creating modern molecular and next generation sequencing (NGS) assays to test for adventitious agents in cell banks and bulk harvests. Developing and implementing strategy for introducing these methods into new and commercial regulatory filings.

+ Reviewing and enhancing protocols for viral detection, containment, and decontamination in laboratory and manufacturing environments

+ Periodically testing program effectiveness to ensure operational excellence

+ Overseeing the GMP aspects of the viral clearance assurance program to support regulatory filings while collaborating with internal and external laboratories to maintain compliance

+ Leading investigations and troubleshoot equipment, testing, and process abnormalities related to virology, addressing virological abnormalities and implementing corrective actions

+ Representing QC Virology during regulatory inspections and audits

This job might be for you if you:

+ Have strong experience in virology within the biotechnology/pharmaceutical industry and a commitment to staying current with advancements in the field

+ Have proven experience participating in regulatory inspections and defending positions during audits or inspections

+ Stay current with technical and professional literature, ensuring the facility complies with domestic and international regulations concerning viral safety

+ Serve as a role model, fostering a culture aligned with Regeneron’s mission, vision, and values

+ Can lead and participate in cross-functional project teams

To be considered for this role you ideally should have a PhD in virology or a related field and must have 10+ years in GMP biopharmaceutical/pharmaceutical environment, with at least 5 years in a management role. Experience presenting/defending positions in audits or regulatory inspections is required. We may consider relevant experience in biopharmaceutical virology in lieu of advanced degree.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$169,600.00 - $282,600.00