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Sr. Microbiologist

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Company: Regeneron Pharmaceuticals

Location: Rensselaer, NY

Date Posted: July 27, 2014

Source: Regeneron Pharmaceuticals

2042BR
Job Posting Title: Sr. Microbiologist
Person Type: Regular
Posting Category QA, QC & Quality Auditing
Location: Rensselaer
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 ...
2042BR
Job Posting Title: Sr. Microbiologist
Person Type: Regular
Posting Category QA, QC & Quality Auditing
Location: Rensselaer
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 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, disability status, protected veteran status, or any other characteristic protected by law.
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