QC Virology Analyst

Role Summary

Regeneron is seeking a QC Virology Analyst for a first-shift schedule (Mon–Fri, 8:00 a.m.–4:30 p.m.). The role is to detect adventitious agents in bioreactors and perform required testing to ensure timely results are released to manufacturing for clinical and commercial products.

Responsibilities

• Perform routine testing for adventitious agents with molecular and cell-based assays for in-process commercial and clinical products.
• Review testing data for conformance with cGMP and assist with investigations of laboratory and/or process deviations.
• Help with receipt of samples from manufacturing.
• Maintain mammalian cell lines in the Cell Culture laboratory to support cell-based assays.
• Assist with laboratory maintenance activities (e.g., equipment cleaning).
• Assist with administrative tasks associated with testing or the Viral Safety program.
• Ensure the laboratory remains compliant and perform weekly checks to ensure good laboratory practices are followed (e.g., discarding expired material, good documentation).
• Maintain a safe, clean and compliant working environment for self and others.
• May run experiments to support method development and/or validation.

Qualifications

• BS/BA in Cell Biology, Microbiology, Biochemistry or related Life Science; or an equivalent combination of education and experience.
• For the various levels, Associate QC Analyst requires BS/BA in Cell Biology, Microbiology, Biochemistry or related Life Science; or an equivalent combination of education and experience; QC Analyst requires 12–18+ months of related experience; or an equivalent combination of education and experience; level is determined by qualifications relevant to the role.
• Willingness and ability to work Monday–Friday, 8:00 a.m.–4:30 p.m.

Skills

• Experience with mammalian cell culture, aseptic technique and In Vitro and/or PCR.
• Ability to perform structured, routine work.
• Ability to handle competing priorities.
• Ability to participate in projects in addition to routine lab work.
• Are a critical problem solver and can apply fundamental and complex troubleshooting methods.
• Enjoy data gathering and data trending to support testing and investigations.
• Willingness to wear appropriate PPE to get the job done safely.
• Can handle continuous work under Biological Safety Cabinet and Microscope.

Education

• BS/BA in Cell Biology, Microbiology, Biochemistry or related Life Science.

Additional Requirements

• Shift and physical requirements: ability to perform physical requirements for up to 10 hours per shift, including bending, climbing, crawling, kneeling, reaching, sitting, standing, walking, driving, hand manipulation, and the ability to lift/push/pull up to 20 lbs.
• Gowning and cleanroom environment: full cleanroom attire and PPE; ability to remove jewelry, makeup and nail adornments when wearing cleanroom attire.