Senior Manager QC Microbiology - Vaccine
Pearl River, New York, Meriden, Connecticut
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Position: Senior Manager QC Microbiology
Location: Pearl River, NY
Who You Are:
You are a dynamic leader with extensive experience in managing multi site cGMP Microbiology laboratories and EM programs in high throughput fast paced manufacturing and testing environments. Alongside managing the laboratories, you will be a resource for all matters related to Sterility Assurance for two sites. You will establish good practices and continuous improvement programs in your area of responsibility and manage and develop a team covering the Pearl River and Meriden sites. You are a multi-tasker with the ability to adapt to changing priorities in line with business needs.
Who We Are:
We are a QC organization supporting testing activities for commercial and development (pipe line) projects spanning multiple areas of treatment for Sanofi Biologics. The scope of our activities include all routine QC/Micro testing for Drug Substances, Drug products, In process , Raw material and stability samples conducted internally as well as external testing sites.
Where We Are:
Pearl River is located in Orangetown, south of Nanuet and west of Blauvelt. Pearl River is a hamlet near the New Jersey border. Commuters still run to catch the train at the old station near the post office. The town is located within 35 miles of New York City.
Manage all microbiological testing and environmental monitoring activities at PSC sites in Perl River and Meriden. Assure all microbiological testing covering all production activities is in compliance with multiple compendia and verify/qualify methods as appropriate. Manage all test methods, SOP’s validations pertaining Microbiological and Utility monitoring tests.
Manage all EM excursions OOS/OOT events and drive deviations to closure in a timely manner. He/She will also be responsible for managing any resultant Corrective Actions and Preventive Actions (CAPA’s) and Change controls.
Provide subject matter expertise for issues related to sterility assurance at both sites.
Serve as technical mentor to direct reports and ensure that the staff is adequately trained and qualified. Develop personnel in the functional area and initiate/manage succession plans for critical roles in the QC Microbiology group.
Where necessary support EMPQ’s, Media Fills and APS’s in manufacturing areas and participate in interdepartmental projects representing QC Microbiology.
Manage all data trending for the functional area and generate reports as per site procedures and regulatory expectations.
Serve as the SME for QC Microbiology during regulatory audits and IND initiatives .
Maintain the QC Microbiology testing areas in a safe and complaint manner. Initiate continuous improvements and laboratory efficiency efforts. Lead data integrity efforts.
BS/MS in Microbiology/Virology with more than 8-10 years of experience in a cGMP laboratory supporting biologics manufacturing with through understanding of regulatory expectations from multiple jurisdictions.
Expertise in routine Microbial testing such as Endotoxin, Bioburden, Sterility, and facility support in EM Utility/Personnel monitoring, A thorough understanding of evolving methods in Microbiology.
Good Organizational, verbal communication, and written skills is required. Basic computational skills including Microsoft Word and Excel are required.
Ability to serve as the technical expert for outsourced testing such as adventitious agents and Mycoplasma testing.
Experience in data trending, and statistical methodologies in a manufacturing environment.
Experience with laboratory electronic systems. (SoftMax ,LIMS, MODA etc.)
Terms of Employment:
Approximately 30% travel between the Meriden and Pearl River testing sites.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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