Senior Director, Cell Therapy CMC/ Process Development
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.
- 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.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is 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. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.