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Sanofi Group Upstream Process Engineer - Vaccine in Swiftwater, Pennsylvania

POSITION OVERVIEW

The Upstream Process Engineer serves as a subject matter expert (SME) and point of contact for bacterial fermentation and cell culture (insect cell culture and baculovirus platform) within the Manufacturing Technology department of Sanofi Pasteur.

Key Responsibilities:

  • Design, execute, and lead development, improvement, and tech transfer activities for the Upstream manufacturing processes used to manufacture both bacterial polysaccharide and recombinant protein (cell culture based) vaccine antigens.

  • Participate in global network for bacterial fermentation and cell culture, within Sanofi.

  • Interface with commercial production facilities to ensure successful process transfer and regulatory filings.

  • Evaluate new technology including external collaborations for improved process understanding.

  • Develop and execute protocols/reports for supporting the tech transfer, scale-up and process validation of upstream biological processes including definition of experimental plans, statistical analysis, protocol scope, resource requirements and objectives to ensure successful execution of projects and definition of design space.

  • Lead upstream pilot scale runs.

  • Provide person in plant support for manufacturing activities and troubleshooting efforts when needed.

  • Project leadership as well as ​coaching and mentoring junior personnel and educating / maintaining technical knowledge in workforce.

  • Influences internally and across Vaccine Industrial Affairs functions; forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement.

  • Fosters cross-functional collaborations with partners and customers, including Analytical Sciences, Quality, Manufacturing, and Regulatory functions.

Basic Qualifications:

  • Minimum Bachelor's degree required (basic sciences, math, engineering, or pharmacy) with 5 + years’ industry experience in biological processes or analytics in a cGMP environment

  • Candidate should possess educational and professional experience, commensurate with the position.

  • High autonomy level, receives guidance with instruction

Other Skills / Competencies:

  • Experience in the design, development, and implementation of industrial cell culture processes for recombinant protein production and/or bacterial polysaccharide conjugate vaccines.

  • Extensive hands-on experience with upstream laboratory activities.

  • Knowledge of bioreactor characterization and engineering principles (mass transfer, mixing, shear, etc.) as well as robust understanding of biochemistry and cell metabolic pathways is a must. Media development experience is a plus.

  • Demonstrated experience with technology transfer to GMP manufacturing facility including providing person in plant and trouble-shooting support.

  • Late-stage process development activities including process characterization and control strategy. Demonstrated ability to evaluate and introduce new technologies to accelerate upstream process development and improve process efficiency. Strong project leadership

  • Excellent verbal and written communication skills.

Preferred Qualifications:

  • A Master’s degree in basic sciences, math, engineering, or pharmacy with 3+ years’ industry experience in biological processes or analytics in a cGMP environment OR

  • A PhD with 1+ years’ industry experience in biological processes or analytics in a cGMP environment.

Location : Swiftwater, PA

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.

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