Manager Viral Safety
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Rensselaer, NY, United States
- Start date
- Feb 20, 2021
View more
- Discipline
- Administration, Training, Clinical, Manufacturing & Production, Safety
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert