Lead QC Virology Analyst

Location
Rensselaer, NY, United States
Posted
Aug 29, 2019
Ref
17426BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Responsible for sample chain of custody, sample processing, testing and test data reporting and archiving.

Level to be determined based on qualifications relevant to the role.

Lead-Related Activities include, but are not limited to, the following:

• Provides on-the-floor guidance an d support to employees;

• Ensures employees timesheets are completed on time;

• Monitors employees training to ensure that all requirements are met, including OJT

• Maintain up to date training records for self and direct reports

• Perform minimally monthly performance feedback meetings with direct reports;

• Escalates all performance issues to management and/or HR;

Essential Duties and Responsibilities include, but are not limited to, the following:

• Ensure proper level of laboratory supplies and reagents and maintain laboratory in an audit readiness stage and cGMP compliant manner always.

• Perform routine and non-routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured in-process commercial and clinical products according to cGMP and associated standard operating procedures.

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

• 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;

• Perform cell culture activities to support virus testing;

• Serve as SME for an assigned assay;

• Assist in data trending, data review, and lab maintenance activities (e.g. cleaning);

• Participate in non-routine projects

• Apply knowledge to assist in investigations and support studies and protocols;

• Responsible for collecting, entering data and generating reports from electronic systems;

• Revise and update standard operation procedures. Display good manufacturing practices and good laboratory practices always.

• Ensure quality and safety of manufactured products. Follows established safety and environmental guidelines and procedures for all work performed;

• Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions; fosters a positive safety culture.

Education and Experience:

• BS/BA in Cell Biology, Microbiology, Biochemistry, or related Science and 1+ years of relevant experience.

• Or equivalent combination of education and experience.

• Experience with mammalian cell culture preferred.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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