Senior Process Engineer, Cell Culture Tech Transfer and Production Support

Overview:

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 cell culture processes across the Sanofi GMP manufacturing network according to the program timelines. The (BPE) department serves as a general lead for clinical transfers and sending lead for commercial transfers. The primary accountability of this role is to partner with all relevant functions from R&D and Industrial Affairs to enable and support successful clinical and commercial manufacturing,

Key Responsibilities:

• Lead technical transfer activities including authoring technical transfer documents and performing facility-fit, risk, and operational readiness assessments

• Lead evaluation and implementation of new process platforms and manufacturing technologies

• Serve as Person-In-Plant (PIP) for critical steps during manufacturing campaigns

• Act as a data steward for all involved functions (Development, GMP manufacturing, and Analytics)

• Organize regular review meetings during GMP campaigns with updates on process performance, deviations, and root causes

• Act as cell culture SME to close deviations and define effective CAPAs to resolve complex problems or process anomalies 

• Work collaboratively with other functions to streamline ways of working

• Maintain and update the BPE knowledge base of equipment and operation specifications across the entire Sanofi manufacturing network.

Basic Qualifications:

• Bachelor's degree with a minimum of10 years of relevant industry experience in manufacturing and/or process development of biologics or a Master's degree with a minimum of 8 years of relevant industry experience

• 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.

Preferred Qualifications:

• Experience in writing and revising protocols, procedures, reports and other process related documentation as necessary to support process scale-up, transfer, and implementation to cGMP manufacturing operations

• Working knowledge in recombinant protein GMP manufacturing, quality standards, and regulatory requirements

• Experience in defining process control strategy and process validation and performing risk assessment following the QbD principle

• Experience in coding to maintain and/or implement automatic process monitoring and analytics system

Special Working Conditions:

• Ability to gown and work in manufacturing areas

• Ability to work flexible hours

Working in BioProcess Engineering

Working in Bioprocess Engineering provides a unique opportunity for professional exposure to many facets of the business.  Successful programs must work 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.

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.