Manager - Upstream MSAT

Job Title: Manager - Upstream MSAT

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

Sanofi’s Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing entities, playing an instrumental role in enhancing our current portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Global MSAT is a beacon of innovation and process excellence in Manufacturing, this includes guiding the journey of new products from their launch to commercial success, being at the forefront of Data Sciences and Digitalization.

Join a team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modeling to successfully launch 3 to 5 new products per year.

 The successful candidate will manage a group of scientists and engineers responsible for technical oversight and support of commercial mammalian cell culture processes at external manufacturing sites. We are looking for a candidate with excellent scientific, communication, and leadership skills.  This individual will work in a fast-paced team environment, collaborating with colleagues across functions in the organization meet department and site deliverables.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Lead and develop a team of Upstream scientists and engineers provide technical support and routine process monitoring for commercial products manufactured at CMOs.

• Provide person-in-plant support of manufacturing operations at CMOs and communicates observations to the product team.

• Work closely with CMO MSAT, oversee and report on overall manufacturing progress.

• Review manufacturing batch records, production data, deviations, and protocols/reports.

• Become SMEs of manufacturing processes, by reviewing process descriptions, development reports, control strategies, etc.

• Provide technical support and data analysis for investigations and deviation resolution.

• Work collaboratively with MSAT Process Science team, recommend changes and/or study plan to improve process robustness and yield.

• Interact with internal and external partners such as other functions in MSAT, External Manufacturing & Supply operation, Engineering, and Quality.

• Support tech transfer, facility fit assessments, and process validation activities at CMOs.

• Support regulatory filings and inspections for the processes manufactured at CMOs.

• Manage resource planning and prioritization of activities, oversight of delivering on commitments in respective areas.

• Coach and develop the team - mentor and develop each member both in execution of responsibilities and in personal development. Establish a high-performance team that fosters accountability, open communication, people development and continuous improvement.

About You

Education & Experience:

• Bachelor’s degree with 9 years, or Master’s degree with 7 years, or PhD with 5 years in industrially relevant biologics development, bioprocess engineering, technology transfer and/or commercial manufacturing operations

Soft and technical skills:

• Excellent scientific and engineering background, technical writing, and presentation skills

• Experience in managing, coaching, and developing scientific and engineering staff or leading matrix managed teams

• Experience with Good Manufacturing Practices and supporting commercial manufacturing operations

• Experience with advanced process monitoring, data analysis, and CPV

• Experience with change assessment, product impact assessment, and quality event management

• Hands-on experience with mammalian cell culture operations at laboratory, pilot, or manufacturing scale

• Experience with upstream process development / characterization, technology transfers, PPQ, and process control strategy establishment

• Experience with authoring regulatory filings and supporting PAI and other health authority inspections.

• Highly motivated individual with the ability to influence cross-functional and cross-site teams and to effectively communicate with project leaders and department and site management

• Flexible with ability to adjust to a fast-paced, goal-oriented environment and willingness to expand and broaden skillset.

Languages:

• English

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.