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Senior Microbiologist 1977BR

Company Name:
Regeneron
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.
Summary: Responsible for QC microbiological aspects of cGMP compliance and testing.
Essential Duties and Responsibilities include, but are not limited to, the following:
Responsible for QC microbiological aspects of cGMP compliance and testing.
Perform microbiological validations as needed for finished product and in process controls and buffers.
Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
Participate in cleaning and process validation activities involving microbiology as needed.
Participate in the investigation of microbiological product OOS results and DNF as needed.
Contribute to the preparation of technical proposals, amendments, reports and memoranda.
Contribute toward creating and revising microbiological SOPs.
Assist in scheduling of M/C and post incursion monitoring procedures with follow-up responsibility to provide test results.
Assist in the review of EM and product release data.
Experience and Required Skills:
Education and Experience:
Requires BS/BA in Biochemistry, Chemistry, Biology or related field with 5+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries. Must have experience with pharmaceutical documentation practices and demonstrated leadership skills.
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 Regenerons unwavering commitment to combining good science & good business.
Apply online at:
http://careers.regeneron.com/rensselaer/industrial-operations-%EF%B9%A0-product-supply/jobid5259239-sr.-microbiologist-jobs

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