Associate Director, Commercial Cell Culture Development

Associate 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

• 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
  

• 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
  

• 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.