mRNA Manufacturing Quality Lead
Waltham, Massachusetts
Overview
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Success Profile
Do you have what it takes for a successful career with Sanofi?
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- Results-driven
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- Leadership
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Culture: Play to Win
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Benefits
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Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
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Financial
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
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Culture
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
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Work/Life Balance
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
Quote
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
Shannon Resetich
US Head Rare Diseases & Blood Disorders
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
Mouhamed Gueye
US Head Medical Rare Blood Disorders
Responsibilities
JOB TITLE: mRNA Manufacturing Quality Lead – GMP Clinical Manufacturing
DEPARTMENT: mRNA CoE Internal Manufacturing (US)
REPORTS TO: Sr. Director, GMP Clinical Manufacturing (Internal)
JOB SUMMARY:
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.
PRINCIPAL DUTIES:
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
JOB QUALIFICATIONS
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.
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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.
