Senior Manager QC Testing - Vaccine
Pearl River, New York, Meriden, Connecticut
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Location: Meriden, CT and Pearl River NY
Who You Are:
You are a dynamic leader with extensive experience in managing multi-site cGMP Microbiology laboratories inhigh throughput fast paced manufacturing and testing environments. You will be a hands on scientist with extensive experience in testing methodologies for Biologics/Vaccine testing methods. Alongside managing the laboratories, you will be a resource for all matters related to Product release and Raw material testing. 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 (pipeline) 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:
Meriden is located at the Crossroads of Connecticut, being bisected by two of the State’s major freeways (I-95 and (91), Meriden is situated midway between the cities of New Haven and Hartford, located about 20 miles to the north and south, respectively. Train service is available from the State St. station. The City is located within 25 miles of several world-class educational institutions.
Manage all QC/Analytical testing activities for Drug Substances , Drug Products In process and Stability samples at the PSC manufacturingsites in Meriden and Pearl River. The role Includes the management of all test methods , Method qualifications/Validations/transfers and release of test data for continuous business operations.
Provide technical leadership in all matters related to Analytical methods and serve as the Subject Matter expert. Manage OOS,OOT and any aberrant result investigations related to the functional area. Manage corrective and preventive actions, change controls and other compliance related activities.
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 Release group.
Represent Quality Control at various Project, Product and Process Team Meetings as designated. Serve as the SME for QC during regulatory audits and IND initiatives .
Maintain the QC testing areas in a safe and complaint manner. Initiate continuous improvements and laboratory efficiency efforts. Lead data integrity efforts.
Conduct additional activities as directed by Management.
BS/MS in a scientific discipline (such as Chemistry/Biochemistry/Biological Science)with at least 8 years' experience in a cGMP laboratory setting.
Strong analytical skills including practical experience of chemical/biological/immunochemical assays in Biologics/Vaccines.
Demonstrated history of ability to work with minimal supervision in a fast-paced manufacturing environment
Data scientist with basic understanding/training in statistical concepts and experience with statistical programs(JMP) is desired.
Good Organizational, verbal communication, and written skills is required. Basic computational skills including Microsoft Word and Excel are required.
Experience in data trending, Control charts and statistical methodologies in a manufacturing environment.
Experience with laboratory electronic systems. (Empower, SoftMax ,LIMS 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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