mRNA Engineer, GMP Clinical Manufacturing - Vaccine
Waltham, Massachusetts
Overview
From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.
Success Profile
Do you have what it takes for a successful career with Sanofi?
- Courageous
- Results-driven
- Proactive
- Problem-Solver
- Leadership
- Team player
Culture: Play to Win
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Growth
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Innovation
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Efficiency
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Collaboration
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 SUMMARY
The Engineer - GMP Clinical Manufacturing reports to the Senior Director, Internal Manufacturing and is responsible for Phase I/II clinical manufacturing as an integral part of the mRNA Center of Excellence (CoE) GMP Clinical Manufacturing team. In this position the Engineer will lead the team in the manufacturing of drug substance and bulk drug product and ensure these intermediate products meet the required specifications. The Engineer may also perform development batches and/or be the lead for technology transfers of new formulations and processes from the development group.
PRINCIPAL DUTIES
Provide hands-on leadership for execution of cGMP clinical manufacturing campaigns for mRNA and nanoparticle manufacturing processes.
Actively plans short term and long-term batch execution including Master Batch Record approval and associated SOP’s.
Leads on technical support for manufacturing issues and helps develop solutions to improve process efficiency and product quality.
Spearheads investigations and ensures all quality events are addressed appropriately.
Effectively communicates with cross functional teams like Analytical Development, R&D, Process Development, and Project Management.
Prepares technical reports and presentations that support manufacturing campaigns, scale-up activities, and process improvements.
Trains associates and manufacturing technicians.
Provides direction to CMO staff to ensure raw materials and consumables are provided in a timely manner and clean room suites are meet cGMP expectations.
JOB QUALIFICATIONS
A Bachelor’s degree and/or Master’s degree in Chemical engineering or related field with 3-7 years of relevant experience is required.
Demonstrated experience in the support of cGMP manufacturing of drug substance or drug product is desired.
Excellent organizational and communication skills.
Strong analytical and problem-solving 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.
