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Senior Director, Cell Therapy CMC/Process Development Lead
1 month ago
Stratacuity is seeking a Senior Director to lead process development, 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.
- 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.
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. 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.
