Senior Director, Cell Therapy CMC/Process Development Lead

5 days ago


Cambridge, Massachusetts, United States Apex Systems Full time
Job Title: Senior Director, Cell Therapy CMC/Process Development

Apex Systems is seeking a highly experienced Senior Director to lead process development, process scale-up, optimization, and technical transfer of Cell Therapy Products. This role will work closely with Contract Development and Manufacturing Organizations (CDMOs) for process development and manufacturing activities.

Key Responsibilities:
  • Provide strategic and technical CMC leadership for developing innovative, scalable expansion and differentiation processes to manufacture cell therapy products.
  • Provide technical support and leadership to oversee and troubleshoot manufacturing during clinical production at CDMOs. Provide person-in-plant support, as needed.
  • Recruit, train, develop, and mentor staff.
  • Support process development efforts in the lab as needed.
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 Apex Systems:

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.



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