Manager, 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: Responsibilities will include but are not limited to: leading and being a team member for microbiologically based initiatives such as, reviewing Drug Product (DP) Contract Manufacturing Organization (CMO) deviations and processes and IOPS Drug Substance (DS) investigation activities, implementation of Continuous Improvement (CI) projects, performing microbial data collection and analysis, and supporting cGMP training and coaching across IOPS.

Basic knowledge of Biopharmaceutical process, equipment and utility validation, DS manufacturing, and DP Formulation/Filling required.

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

• Ability to foster working relationships between multiple Regeneron departmental representatives. Must maintain current knowledge in microbiological practices and methods as they relate to industry and Regeneron expectations;

• Lead teams for common company objectives and projects as needed.

• Observe manufacturing operations on the floor to provide constructive feedback for strengthening microbial controls and aseptic practices;

• Aid in investigations pertaining to microbial controls either as a self-directed individual or as part of a group effort;

• Provide input on technology transfer plans related to microbiological method transfers and new technology;

• Review and provide input on SOPs, microbiology assay validation, sterilization and related documentation in support of biopharmaceutical manufacturing and testing;

• Review and provide input on environmental monitoring SOPs and validation;

• Support the work and efforts of QA Microbiology, QC, and Manufacturing training groups;

• Aid in quality audits of CMOs as the microbiology expert, providing feedback and aid in generation of audit reports;

• Some Domestic and foreign travel required.

Education and Experience:

• Associate Manager - Requires Bachelors in Microbiology/Life Science field and a minimum of 6 years relevant experience in the pharmaceutical/biotechnology or related industry with at least 2 year in a leadership role.

• Manager - Requires Bachelors in Microbiology/Life Science field and a minimum of 7 years relevant experience in the pharmaceutical/biotechnology or related industry with at least 2 year in a leadership role.

• Sr Manager - Requires Bachelors in Microbiology/Life Science field and a minimum of 8 years relevant experience in the pharmaceutical/biotechnology or related industry with at least 2 year in a leadership role.

• Knowledge of current industry microbial aseptic practices required.

• Must be able to enter and work in aseptic controlled environments.

• Relevant experience may be considered in lieu of the educational requirement.

• Audit and/or working experience in Sterile filling operations required.

• Knowledge of EU and FDA regulations strongly required.

*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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