Senior Director, Cell Therapy CMC/Process Development Lead

3 weeks ago


Cambridge, Massachusetts, United States Stratacuity Full time

Job Overview:

At Stratacuity, we are seeking a highly experienced Senior Director to lead our Cell Therapy CMC/Process Development team. As a key member of our organization, you will be responsible for developing innovative, scalable expansion and differentiation processes to manufacture cell therapy products.

Primary Job Responsibilities:

  • Provide strategic and technical CMC leadership for developing cell therapy products.
  • Lead process development, process scale-up, optimization, and technical transfer of cell therapy products.
  • Provide technical support and leadership to oversee and troubleshoot manufacturing during clinical production at CDMOs.
  • Recruit, train, develop, and mentor staff.
  • Support process development efforts in the lab as needed.

Primary Job Requirements:

  • PhD with 10+ years or BS/MS with 15+ years of experience and strong team leadership experience.
  • Broad technical expertise in human pluripotent stem cell culture and differentiation or in scale-up of allogeneic cell therapies.
  • Direct experience working with CDMOs and supporting tech transfer and/or GMP clinical manufacturing operations.
  • Experience supporting regulatory filings and interactions with the FDA.

About Stratacuity:

We are an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.



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