mRNA Manufacturing Quality Lead
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JOB TITLE: mRNA Manufacturing Quality Lead – GMP Clinical Manufacturing
DEPARTMENT: mRNA CoE Internal Manufacturing (US)
REPORTS TO: Sr. Director, GMP Clinical Manufacturing (Internal)
The mRNA Manufacturing Quality Lead reports to the Senior Director, Internal Manufacturing and is responsible for Phase I/II clinical manufacturing quality support as an integral part of the mRNA Center of Excellence (CoE) GMP Clinical Manufacturing team. In this position the mRNA Manufacturing Quality Lead will support quality and validation activities in the manufacturing of drug substance and bulk drug product. The mRNA Manufacturing Quality Lead may also perform development batches and/or be the lead for technology transfers of new formulations and processes from the development group.
Assist manufacturing staff with documenting and tracking of Quality Events.
Review new and executed batch records.
Represent manufacturing during internal quality audits.
Perform GAP analysis of local versus global procedures.
Assess vendor change notifications.
Assist manufacturing in completing new asset on-boarding.
Act as liaison with Metrology/Validation team
A bachelor’s degree in a scientific discipline with 5-10 years of relevant experience is required.
Strong knowledge of all aspects of a Quality Management System.
Demonstrated experience in the support of clinical cGMP manufacturing.
Excellent organizational and communication skills.
Able to work in a fast-paced environment.
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.