Deputy Director, Upstream Sr. Scientist
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The Deputy Director, Upstream Sr. Scientist serves as a subject matter expert (SME) and point of contact for bacterial fermentation and cell culture within the Manufacturing Technology department of Sanofi Pasteur.
Location: Swiftwater, PA
Defining and leading 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.
Participating in global network for bacterial fermentation and cell culture, within Sanofi.
Strategic vision on the future of bacterial fermentation and cell culture and its implementation on the Swiftwater site.
Evaluating 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.
Minimum Masters degree required (in basic sciences, math, engineering, or pharmacy) with 6+ years’ industry experience in biological processes or analytics in a cGMP environment OR
PhD with 1+ years’ industry experience in biological processes or analytics in a cGMP environment.
Candidate should possess educational and professional experience, commensurate with the position.
Other Skills / Competencies:
Proven track record of accomplishments 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.
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