Upstream Technical Pilot Plant USP Lead
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We are seeking a highly motivated individual to join the BioProcess Engineering (BPE) department, part of the Sanofi Global CMC Development organization, in the role of Upstream Technical Pilot Plant Lab USP lead. This role is accountable for Technical Pilot Plant (TPP) upstream production for early and late stage fed batch and continuous biologics production for monoclonal antibodies and other biological therapeutics. The role will work with the BPE teams to produce candidate molecules under development to support CMC and technical transfer activities. The USP TTP Cell Culture lead will interface with the USP BioProcess development and BPE DSP teams to transfer processes into the TPP for biological production at the 100L/500L scale. The role will oversee the readiness of the TPP USP equipment and process development studies and interface with Drug Substance teams
Oversee USP TPP team in the production of MAB and other Biological therapeutics at the 500L scale (MAB) and 100L/500L scale (Continuous).
Ensure process equipment readiness and update process equipment with the Engineering group.
Evaluate new process platforms and manufacturing technologies for potential implementation with BioProcess development and BPE Tech transfer groups.
Responsible for production batch record generation. Responsible for updating molecule specific documentation and process SOP’s.
Participate in regular review meetings during development campaigns with updates on process performance, deviations, and root causes.
Assist in Technical Pilot Plant build out final design and equipment purchase.
Act as cell culture Subject Matter Expert (SME) to BPE and development groups.
Work collaboratively with other functions to streamline ways of working.
Maintain and update the BPE knowledge base of equipment and operation specifications.
Implement digital documentation systems for cell culture processes.
PhD in Chemical Engineering, Biochemistry, Biotechnology, or related discipline with 4 years’ experience or a master’s degree with 8 years or Bachelor's degree with 10 years of relevant industry experience in manufacturing, Pilot Plant, and/or process development of biologics
Experience in leading matrix teams.
Excellent communication skills
Experience working on multiple complex projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.
Experience in manufacturing or process development of biologics with mammalian cell culture
Knowledge on scale-up, process transfer, and cGMP manufacturing operation.
Experience in writing and revising protocols, procedures, reports, and other process related documentation as necessary to support process scale-up, implementation.
Experience with Delta-V or other manufacturing control systems.
Working knowledge in recombinant protein GMP manufacturing, quality standards, and regulatory requirements
Experience in defining process control strategy and performing risk assessment following the QbD principle
SPECIAL WORKING CONDITIONS
Ability to gown and work in manufacturing areas
Ability to work flexible hours
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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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