Purification Tech Transfer Engineer
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We are seeking a highly motivated Process Engineer to join the BioProcess Engineering (BPE) department, part of the Sanofi Global CMC Development organization. This role is accountable for rigorous and efficient transfer and implementation of purification processes across the Sanofi GMP manufacturing network according to the program timelines. This role will serve as a general/receiving lead for clinical transfers and sending lead for commercial transfers, with primary accountability to R&D and Industrial Affairs departments.
Working in Bioprocess Engineering provides a unique growth opportunity for professional exposure to many facets of our global business. Successful programs must collaborate with many departments such as Operations, Development, Quality, Supply Chain, CMC, and Regulatory. This can be an ideal place for those looking for new and interesting challenges and experiences.
Lead technical transfer activities, including facility fit, gap, and risk assessments, as well as provide technical support as SME for implementation of purification processes at pilot and clinical scale.
Writing and review of technology transfer plans, process descriptions, control strategies, and campaign summary reports.
Perform Continued Process Verification (CPV) during campaign execution and organize review meetings with stakeholders to provide updates on process performance and deviations.
Act as the primary data steward for program development runs, scale-up pilot batches, and clinical manufacturing. Generate data visualizations for CPV, assessments, and root cause analysis.
Serve as Person-In Plant (PIP) for critical steps during manufacturing campaigns.
Act as SME for deviation investigations and CAPA planning to resolve complex process issues.
Lead evaluation and implementation of new process platforms and manufacturing technologies in collaboration with internal partners and external vendors.
Work collaboratively with members of other functional departments to streamline ways of working for tech transfer, CPV, and manufacturing operations.
In partnership with the global BPE team, maintain and update the knowledge base of equipment and operational specifications across the entire Sanofi manufacturing network, share best practices in tech transfer, and drive continuous improvement.
Bachelor’s degree in Chemical Engineering, Biochemistry, Biotechnology, or related discipline with a minimum of 6 years industry experience in GMP batch manufacturing, manufacturing readiness, or process development of biologics OR a Master’s degree with minimum of 4 years relevant industry experience OR Ph.D. with relevant industry experience.
Experience with a wide variety of purification techniques and products for use in recombinant protein purification systems, with knowledge on scale-up, process transfer, and cGMP manufacturing operation.
Experience participating in large, cross-functional teams.
Excellent oral and written communication skills.
Experience working on multiple complex projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.
Experience in writing and revising protocols, procedures, and reports as necessary to support process scale-up, transfer, and implementation to cGMP manufacturing operations.
Working knowledge of cGMP manufacturing, quality, and regulatory requirements (FDA, EMA, ICH).
Experience in defining process control strategies and performing risk assessment following Quality by Design (QbD) principles.
Familiarity with statistical analysis techniques and packages (JMP).
Experience working with external partners and/or CDMOs.
Experience in manufacturing or process development of antibody-drug conjugates and/or enzymes.
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.
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