ResponsibilitiesThe Manager is responsible for facility operations, personnel, quality systems, equipment, documentation, and regulatory readiness in accordance with applicable FACT, FDA, cGMP, cGTP, CLIA, CAP, and organizational requirements. Working collaboratively with clinical, research, quality, regulatory, and industry partners, the Manager ensures high-quality cellular therapy operations while advancing program capabilities, continuous improvement, and operational excellence.
Qualifications
Education:o Bachelor's Degree in Clinical Laboratory Science, Medical Technology, Biological Science, Biomedical Science, or a related field that meets California requirements for Clinical Laboratory Scientist licensure required.
Preferred:o Master's Degree in Clinical Laboratory Science, Stem Cell Biology, Cell Biology, Molecular Biology, Immunology, Biotechnology, Biomedical Sciences, or a related field preferred.
Experience:o Five (
5) years of progressively responsible experience in cellular therapy, cell processing, clinical laboratory operations, GMP manufacturing, or a closely related regulated laboratory environment required.o Experience working within regulated quality systems, including SOPs, deviations, CAPAs, validation, and regulatory or accreditation requirements required.
Preferred:o Experience managing or providing technical leadership within a cellular therapy processing laboratory or GMP manufacturing facility, including participation in FACT, FDA, CAP, CLIA, or other regulatory or accreditation inspections preferred.o Experience supporting commercial or investigational cellular therapy products, clinical trials, technology transfer, or advanced cellular therapy programs preferred.o Experience with hematopoietic stem/progenitor cells, autologous or allogeneic cellular therapies, GMP-grade cell lines, vectors, MSCs, hESCs, iPSCs, or other advanced cellular products preferred.
Licenses and Certifications:o State of California Clinical Laboratory Scientist License required
Disclaimers
• Pay ranges listed are an estimate and subject to change.• If any bonuses are noted, they are only applicable to external hires meeting criteria.
