Manager Viral Safety

Location
East Greenbush, New York, United States of America
Posted
Jul 24, 2021
Ref
23710BR
Required Education
Bachelors Degree
Position Type
Full time
The Manager of advanced therapy medicinal products (ATMP) Viral Safety is a driven subject matter specialist and leader in the laboratory, supporting multiple areas of the organization. These areas

include MAb and ATMP Manufacturing, Process Sciences (PS) and Quality Control (QC). We are

looking for someone who can actively guide each area through the insurance of viral safety for

advanced therapy medicinal products (ATMPs) at IOPS.

As the Manager of ATMP Viral Safety, a typical day might include the following:
• Guiding and coordinating the Viral Safety Program as an expert for viral clearance validation

review at IOPS as well as manufacturing investigations of upstream and downstream processing
• Improving the tripod PREVENT-DETECT-RESPOND to viral contamination for both MAbs and

ATMPs
• Developing holistic understanding and IOPS strategy for the best viral safety and control practice while performing training with QA and EHS
• Executing and supervising viral safety project management to contribute to the response/filing of Regulatory information requests
• Reviewing pertinent Regulatory dossier sections by writing GMP documentation
• Conducting viral safety risk assessment for ATMPs manufacturing and QC lab practices (assay development, transfer and testing i.e. cell and molecular based assays, automation, rapid micro and Next Generation Sequencing +bioinformatics)

This role might be for you if:
• You demonstrate proven technical writing skills
• You are a strong communicator and work well with others
• You can work across the entire enterprise effectively while maintaining flexibility

To be considered for this role a PhD in Life Sciences, or a related field, is preferred but not required with 7+ years of proven experience. Experience in the biotechnology industry (process sciences, virology, molecular biology or virology, biochemistry, gene therapy) is preferred. Previous supervisory experience is required. We need someone who will continuously strive to improve processes to then improve performance.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.