Associate Director, Commercial Cell Culture Development
Framingham, Massachusetts Permanent Date posted 01/05/2024Associate Director, Commercial Cell Culture Development
Location: Framingham, MA
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery anddevelopment to find answers for patients and their families. Your skills could be critical in helpingour teams accelerate progress. Join our global Cell Culture Development (CCD) organization as the Associate Director, Commercial Cell Culture Deveopmentwith the mission to develop robust, scalable and high productivity cell culture processes for Sanofi’s very diverse early and late-stage biologics pipeline. You will be a natural influencer, with the drive to motivate your employees and challenge them to be their best self.
As a senior staff member of Commercial Cell Culture Development, this leader is expected to work collaboratively to establish objectives, priorities and directions for the department, and to represent the function to stakeholders. The leader will
Main Responsibilities
Develop industry-leading high performing, highly scalable and robust commercial cell culture and harvest 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
Author upstream IND and BLA sections and support agency responses.
Actively publish and present externally and pursue IP opportunities for the company.
Serve as a subject matter expert in Cell Culture Development, support the resolution of technical challenges, and Lead innovation projects to develop and implement industry-leading cell culture technologies and platforms.
Build strong interfaces with the global Cell Culture Development community and drive global adoption of best practices
About You
PhD degree in Biochemical Engineering, Chemical Engineering or Bioengineering with at least 5-7+ years of relevant industrial experience, MS + 11 years of relevant industrial experience, or BS and 12+ years of relevant industrial experience.
Proven experience in developing cell culture and harvest processes for clinical and commercial manufacturing
Have CMC experience covering FIH to commercial process development, process characterization, and regulatory submissions
Working knowledge of GMP manufacturing
In-depth knowledge of medium development, bioreactor scale-up principles, scale-down models, tech transfer concepts, and bioreactor engineering
Strong background in CHO cell metabolism, glycosylation and product quality attribute control
Ability to lead a team of scientists, focused on upstream process development, effectively in a matrix organization and cross-functional drug substance development teams
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicantswill receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domesticpartnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liabilityfor military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) orany other characteristic protected by law.
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