Upstream Process Head

Sanofi

Vitry-sur-Seine, France

About the job

The role provides leadership to the Vitry upstream MSAT team responsible for technical oversight and support of manufacturing activities at Vitry site within Sanofi global biologics network. In this role you will lead Commercial Manufacturing Support, Lifecycle Management (LCM) including process improvement of commercial processes, Scale up/Tech Transfer of commercial and late stage clinical processes, Process Validation, and regulatory support.

Main responsibilities

Provide technical leadership to the team of scientists and engineers with background in development and validation of cell culture upstream processes;
Support and safeguard existing production processes by data trending and monitoring, generation of scientific/technical study protocols and reports including small scale lab study in support of significant changes, product impact assessments upon significant deviations in the production process and provided technical advice to questions of other departments;
Work collaboratively with downstream, analytical, CMC project management, CMC regulatory and manufacturing to develop an increased depth of knowledge for the drug substance process for a given product and focus on improving the robustness and economics of commercial manufacturing processes;
Identify process improvements to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scale;
Lead technology transfer, process validation and process control strategy definition for introduction of new products and processes at manufacturing scale;
Manage MSAT lab and use small scale models for studies conducted in lab environment to support commercial manufacturing investigation, LCM, and tech transfer;
Support regulatory filings and inspections;
Work with CMC process development team to establish and implement platform approaches for activities and technologies applicable to upstream operations;
Manage resource planning and prioritization of activities, oversight of delivering on commitments in respective area;
Coach and develop the MSAT Team - mentor and develop each member of the MSAT team both in execution of their responsibilities and in their own personal development. Establish a high-performance team that fosters accountability, open communication, people development and continuous improvement.

About you

Qualifications/Education & work experience

Master or PhD degree in Biological/Biomedical, Sciences/Engineering;
7+ years of biopharmaceutical industry experience in process development, process scale up/manufacturing and process validation;
Experience with large scale manufacturing support for mammalian cell culture processes, current Good Manufacturing Practices, US/EU regulations;
Experience with Tech Transfer and post approval life cycle management;
Proven experience in building, leading and developing high-quality, high-performance teams of scientists and engineers of diverse academic backgrounds and skill levels;
Ability to work in cross-functional and multi-site teams within a global matrix organization;
Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines;
Ability to communicate effectively with internal and external stakeholders on status, needs, forecasts, risks and timelines;
Ability to drive change, innovation, teamwork and competitive performance as well as develop, inspire and motivate a team in the achievement of specific objectives;
Strong verbal and written communication and prevention skills;
Oral and written fluency in English.