Associate Director, QA Microbiology

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: Positon focuses on all microbial aspects supporting Drug Substance bulk cell culture manufacturing by Regeneron Pharmaceuticals, including but not limited cell culture processes, column chromatography, validation activities, contamination controls, clean utilities, all aspect of microbial sampling/testing practices and support of associated investigations. This position will report into the Director QA Microbiology of Regeneron's Industrial Operations and Product Supply (IOPS) organization.

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

• Ability to foster working relationships between multiple departments of Regeneron in support bulk manufacturing microbial control efforts.

• Monitoring operations for microbial control as it relates to Regeneron expectations and industry regulatory agency compliance;

• Aid investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plans determination, product impact, and remediation plans;

• Maintain industry standards with respect to microbial control/ mitigation - aid to monitor and incorporate any new industry standards at IOPS facilities;

• Provide input on technology transfer plans related to microbiological method transfers (method validation) as necessary;

• Review and provide input on SOPs, microbiology assay validation, sterilization and related documentation at Regeneron in support of Drug Substance/ Formulated Drug Substance, (DS/FDS) production.

• Review and provide input on environmental monitoring SOPs and validation

• Maintain consistence of microbial control practices and culture across IOPS facilities

• Domestic and foreign travel required.

Education and Experience:

• Bachelors degree in Microbiology, Medical Technology, Biology or related field and a minimum of 10 years' experience in the pharmaceutical or biotechnology industry.

• Knowledge and experience in cell culture manufacturing, clean utilities, clean room design and operations, and microbial sampling and testing techniques.

• Experience should also include quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals.

*Level will be determined based on skills and related experience.*

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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