Principal Process Engineer – Cell Culture Tech Transfer and Production Support

Job description

Overview:

This role is accountable for rigorous and efficient transfer and implementation of cell culture across the Sanofi GMP manufacturing network according to the program timelines. The role of the BioProcess Engineering (BPE) group is to serve as a general lead for clinical transfers and sending lead for commercial transfers.

Responsibilities:

Responsibilities include but are not limited to partner with all relevant functions from R&D and IA to perform facility fit assessment and authorize transfer documents, specifically:

·  Lead technical transfer activities and provide technical support as SME for cell culture processes.
·  Support GMP manufacturing operations:
·  Serve as People-In Plant (PIP) for critical steps during manufacturing campaigns
·  Organize regular review meetings during GMP campaigns with updates on process performance and deviations
·  Act as technical leader for deviations and CAPA definition to resolve complex process anomalies 
·  Lead authorization of technology transfer plans, technology transfer reports, and campaign summary reports
·  Partner of risk assessment and control strategy definition by providing information and data on facility and equipment capability and constraints
·  Act as a data steward by gathering and compiling process data for projects with the support of all involved functions (Development, GMP manufacturing, and Analytics) for development runs, scale-up batches at technical pilot plant, and GMP batches at  GMP manufacturing including process performance attributes and analytical results. Visualization for reviews, assessments, and process anomaly root cause analysis
·  Lead evaluation and implementation of new process platforms and manufacturing technologies
·  As a senior member of the BPE group, work collaboratively with members of other functions to streamline the interfaces with various partners and represent the function in stakeholder meetings as needed.
·  Along with BPE members at other sites, maintain and update the knowledge base of equipment and operation specifications across the entire Sanofi manufacturing network. Share best practices in tech transfer and implementation and drive continuously improvement.

Basic Qualifications

·  Bachelors or Master's degree in Chemical Engineering, Biochemistry, Biotechnology, or related field with minimum of 12 years industrial experience in manufacturing or process development of biologics
·  Experience in leading matrix teams.
·  Excellent oral and written communication skills to build relationships both inside and outside the company.
·  Experience working on multiple complex projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.

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Preferred Qualifications

·  Experience in manufacturing or process development of biologics, preferred produced in mammalian cell culture systems, with 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, transfer, and implementation to cGMP manufacturing operations

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

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

Special Working Conditions:

·  Ability to gown and work in manufacturing areas
·  Ability to work flexible hours

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.