Jeremy Anderson
Associate Director, Clinical Qc (Car t Cell Therapy) @Kite Pharma
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WORK HISTORY
Associate Director, Clinical Qc (Car t Cell Therapy) @Kite Pharma
Lead and oversee the QC Analytical & sample management functional areas within the clinical QC department (12+ FTEs)-Interim managed the QC Microbiology functional area (10 FTEs)-Supported people development, improved workflow processes, and optimized team capacity model-Ensure QC laboratories and operations are cGMP compliant. This includes ensuring that QC procedures, practices, and analytical methods follow the applicable compendial, regulatory requirements, and industry practices in a phase-appropriate clinical setting-Serve as subject matter expert (SME) for all Analytical methodologies related to Cell Therapy testing to enable the release of clinical drug product. Manage QC analytical methods including Flow Cytometry (%TD), PCR (qPCR for mycoplasma, ddPCR for VCN and RCL/RCR), cell-based potency assays (INFg expression). Support QC micro methods including EM sampling, endotoxin, sterility, and bioburden-In association with the QC Technical Services group, collaborate with new product technology transfers, staff training, and initiate and support quality records (e.g, laboratory investigations, OOS investigations, CAPAs, and Change Controls)-Author, review, and approve test method SOP’s for new SOPs and SOP revisions, study protocols, technical reports, and stability reports-Provide support for CMC activities for Kite products and processes-Maintain the quality control laboratory in an audit-ready state and represent QC Analytical in all Internal and Corporate audits-Lead and participate in Operational Excellence and Lean Six Sigma 5S programs for increased laboratory efficiencies. Cultivate continuous improvements for Kite Analytical operations-Manage inventory tracking and qualification of critical reagents, laboratory supplies, and other requirements to ensure unimpeded testing in QC Analytical function-Mentor QC personnel to increase the level of technical and compliance competency and career development within the team.
EDUCATION
California Lutheran University
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Rutgers University
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
Rutgers University
Master of Engineering - MEng
Point Loma Nazarene University
Master of Business Administration - MBA, Innovation and Entrepreneurship
ABOUT JEREMY ANDERSON
PhD/MBA leader experienced in the pharmaceutical industry with analytical method development, method transfer, GMP testing, quality control, and regulatory inspections/commitments. Experienced with separations methods, and bioassays (in vitro and in vivo assays). Working to improve patient lives by developing and releasing life-saving medicines.
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