Process Engineer III, USP

Department Description:

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.

Key Responsibilities:

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.

• 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 filing

Basic Qualifications:

• Bachelor’s degree in engineering or science with 5 years of experience

OR

• Master’s degree in engineering or science with 3 years of experience

OR

• Ph.D. in engineering or science.

• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations

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

• Knowledge of DeltaV automation

• 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)

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.