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Process Engineer III, USP

Synthorx

Synthorx

Framingham, MA, USA
Posted on Saturday, March 23, 2024

Process Engineer III

Location: Framingham, MA

About the Job

The Recombinant Mammalian DS Platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture-based DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products.

We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate.

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?

  • Provide technical support and routine process monitoring for commercial products manufactured at CMOs.

  • Reviews manufacturing processes, deviations, and/or development and production data.

  • Reviews manufacturing batch records, protocols, and control strategies.

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

  • Represent upstream team as a subject matter expert or technical lead in cross-site, cross-functional teams.

  • Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.

  • Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments.

About you

  • BS or MS in engineering or science with 3-5+ years of experience in biologics development, bioprocess engineering, technology transfer, and /or commercial manufacturing operations

  • Experience with Good Manufacturing Practices and supporting a commercial facility

  • Experience in cell culture (direct lab experience a plus)

  • Experience with equipment qualification and process validation

  • Experience working with statistical analysis software and investigative data analysis

  • Strong technical writing and communication skills

  • Ability to travel (up to 20% of time) and gown and gain entry to manufacturing areas

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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Pursue progress, discover extraordinary

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!