Job Summary and Essential Functions:
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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Overseeing 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. To be responsible for sample chain of custody, sample processing, testing and test data reporting. Ensure proper level of laboratory supplies and reagents and maintain laboratory in an inspection-ready state and cGMP compliant manner at all times. 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 and good laboratory practices at all times. Ensure Quality and Safety of manufactured products as well as safe workplace.
• Manage cGMP lab operation, collect, process and report on data for samples associated with in-process testing for the clinical and/or commercial manufacturing facilities, Oversee cell culture activities to support virus testing.
• Initiate, compile, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information, oversee data trending, data review, metrics and lab maintenance activities (e.g. cleaning).
• Develop business operation model for the virology lab (i.e. capacity planning, activity scheduling, sample projection, and metrics analysis).
• Oversee the contract lab testing program for cell bank and unprocessed bulk (including the cGMP aspect).
• Responsible for developing a strong team of knowledgeable analysts to perform virological testing.
• Enforce 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 in which no one gets hurt.
Knowledge, Skills, and Abilities:
• Must have solid working knowledge in cell culture, virus and mycoplasma assays per ICHQ5A, USP<1237>, Proficient in virus and Mycoplasma testing according to ICH, USP, and E.P, proficient in cGMP practices in all aspects of laboratory assignments.
• Excellent organizational and communication skills.
• Excellent interpersonal and leadership skills.