Director, Commercial Cell Culture Development
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Cell Culture Development within the Mammalian Platform organization is responsible for the development of cell line and cell culture technologies and processes that support all phases of CMC from pre-candidate selection through BLA. As a member of the Cell Culture Development leadership team, this leader will lead and manage the U.S. based group to develop commercial upstream processes for pivotal trials and commercial launches. This team will focus on developing high productivity fed-batch and perfusion processes through medium/feed optimization and process intensification leveraging the cell culture platform. The leader will be responsible for successful process scale-up and transfer ensuring good facility fit across our commercial network. Process characterization, validation and IND/BLA authorship are also part of the commercial development responsibilities. The leader will be a key driver of cell culture innovation with clear line of sight to commercial implementation. The position will require close collaboration with the cell culture platform group, cell line development, purification, tech transfer, and clinical and commercial manufacturing. It will have wide-ranging discretion and independence in driving the commercialization strategy and modernizing our approach for efficiency.
Duties and Responsibilities
Develop industry-leading high performing commercial cell culture and harvest processes
Ensure highly scalable and robust commercial processes
Drive for product quality attribute understanding and control to meet comparability
Deliver thorough process characterization packages using the latest advances in DOE statistical tools, multivariate analysis models and prior knowledge strategy
Drive strategy for process validation
Responsible for upstream CMC activities ensuring successful IND and BLA submissions
Drive technology and organizational development initiatives that improve cost and efficiency
Collaborate cross-functionally to develop and improve commercialization business processes
Develop and manage department goals and budget in line with the broader objectives of the Cell Culture Development and Mammalian Platform organizations
Provide scientific strategy and guidance to staffs. Manage their development and build strong, high-performing teams
Actively publish and present externally. Pursue IP opportunities for the company.
Degree in chemical/biochemical engineering, bioengineering or relevant discipline
BS/MS with 15+ years of relevant professional experience, OR
PhD with 10+ years of relevant professional experience
Proven experience in developing cell culture and harvest processes for clinical and commercial manufacturing
Strong CMC experience covering all aspects of development from FIH to commercial process development, process characterization, and regulatory submissions
Previous leadership experience in successfully managing and developing scientific staffs
Thorough working knowledge of GMP manufacturing with understanding of equipment and process validation
Proven skills in building and maintaining productive relationships with cross-functional partners such as manufacturing, quality, supply chain and regulatory
In-depth knowledge of medium development, bioreactor scale-up principles, scale-down models, tech transfer concepts, and bioreactor engineering
Working knowledge of high-throughput cell culture and automation technologies, process monitoring and control, process modeling and DOE statistics
Strong background in CHO cell metabolism, glycosylation and product quality attribute control
Proven track record of innovation demonstrated by a consistent record of external presentations and publications
Ability to effectively translate innovation into business value that benefits the pipeline and manufacturing
Ability to lead effectively in a matrix organization
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.
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.