Process Engineer III

Job Title: Process Engineer III

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.

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.

Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.

The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group. This group support commercial operations across a diverse network of manufacturing facilities and external partners. Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

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

• 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 an SME 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
• Oversees and reports on overall manufacturing progress.
• Designs and conducts necessary experiments, interprets results.
• May provide technical guidance to less experienced staff.
• May lead small technical project teams and implement project plans.
• May lead technology transfer efforts of small project teams between groups/organizations.
• May support regulatory filings
  
  

About You

Basic Qualifications

• Bachelor’s degree in engineering or science with 5 years of industry experience or master’s degree in engineering or science with 3 years of industry experience
• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations
• Experience with Good Manufacturing Practices and supporting a commercial facility
  
  

Preferred Qualifications

• 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
• Familiarity with formal root cause analysis and/or risk assessment
• Experience working with statistical analysis software and investigative data analysis
• Experience with project leadership
• Experience communicating with cross functional teams
• Strong technical writing and communication skills
• Proficient in Microsoft Word, Excel, and PowerPoint
  
  

Special Working Conditions

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

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.