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Supervisor Quality Control Virology

Employer
Regeneron Pharmaceuticals, Inc.
Location
East Greenbush, New York
Start date
Apr 12, 2024

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Discipline
Quality, Quality Control, Science/R&D
Required Education
Bachelors Degree
Position Type
Contract
Hotbed
Pharm Country, Best Places to Work

Job Details

We are looking for a Supervisor for our QC Virology team! This position is a Monday-Friday, 8am-4:30pm shift. This role is responsible for overseeing routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured commercial and clinical products according to cGMP, ICH guidelines, and associated standard operating procedures. The QCV Supervisor will be responsible for sample chain of custody, sample processing, testing in-house as well as external and test data reporting.

As a Supervisor of QC Virology, a typical day might include the following:

Supervise the contract lab testing program for cell bank and unprocessed bulk (including the cGMP aspect).

Supervise the in-house testing activities.

Ensure cGMP operation (including the CBE30 Submission and Regulatory Inspection).

Regulatory Document Review Virology section (IND, BLA) for accuracy of test results.

Define business operation model for the virology lab (i.e. capacity planning, activity scheduling, sample projection, and metrics.

Proficient in virus and Mycoplasma testing according to ICH, USP, and E.P.

Proficient in cGMP practices in all aspects of laboratory assignments.

Collect, process and report on data for samples associated with in-process testing for the clinical and/or commercial manufacturing facilities.

Apply basic and advanced troubleshooting methods as well as problem solving tools such as A3.

Initiate, compile, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information.

Oversee virus and mycoplasma assays at all levels of complexity to support manufactured products.

Oversee data trending, data review, metrics and lab maintenance activities (e.g. cleaning).

Oversee collection, data entry and generation of reports from electronic systems.

Review and evaluate Lab data for conformance to cGMP and specifications and assist with investigation of laboratory deviations.

Revise and update standard operation procedures. Display good manufacturing practices, good laboratory practices, and ensurie quality and safety of manufactured products.

This role might be for you if you:

Work independently with little supervision and manage a team.

Enforce established safety and environmental guidelines and procedures for all work performed by immediately reporting safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.

Foster a positive safety culture in which no one gets hurt.

Maintain laboratory in an inspection-ready state and cGMP compliant manner at all times.

To be considered for a Supervisor of QC Virology you must be willing and able to work Monday-Friday, 8am-4:30pm. This position requires a BS/BA in Virology, Cell Biology, Microbiology, Biochemistry, or related Science, with 5+ years working in GMP virology lab or related experience.Relevant experience may be substituted in lieu of educational requirement.

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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$76,100.00 - $124,300.00

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

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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