Senior Director, Cell Therapy CMC/ Process Development 2049643

Location: Cambridge, MA (Onsite / Hybrid)

Job Overview: Lead process development, process scale-up, optimization, and technical transfer of Cell Therapy Products working closely with CDMOs for process development and manufacturing activities.

Primary Job 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.

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:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

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