Los Angeles Metropolitan Area
Experienced and strategic Quality Control leader with over 25+ years of progressive responsibility in cell and gene therapy environments. Proven expertise in analytical method development, GMP transfer and qualification, and regulatory compliance. Adept in scaling QC operations, managing cross-site transfers, and leading teams through audits and clinical manufacturing support. Offers technical subject matter expertise bridging R&D, analytical development, and GxP Quality operations to facilitate cross functional collaboration and continuity. Core Competencies include: • Quality Control Leadership | Team Mentoring | GMP/GDP/GLP compliance | Regulatory Submissions • Method Transfer | Deviations/OOS/OOT Investigations | CAPAs | Cross Functional Collaboration | Sample and Inventory Management | External Oversight • Analytical Method Development and Qualification | Flow Cytometry | ELISA | ddPCR/qPCR | Functional assays | Potency
Directly manage QC Analytical associates conducting in-process evaluations, product release, and stability assessments while ensuring cell therapy products meet quality and compliance standards for clinical use while maintaining regulatory adherence. Manage investigations, resolve, and document discrepancies related to testing and analytical processes, and support subsequent investigations, deviations, out-of-specification (OOS) procedures, and Corrective and Preventative Action (CAPA) processes through quality management system. Supervise method transfer activities in collaboration with cross functional teams for analytical testing procedures. Responsibilities include assay method training, generating and executing qualification protocols, facilitating internal QC cross-training, and managing the life cycle of approved test methods Implementation of process improvements to enhance efficiency and accuracy for QC related methods, standard operating procedures, and protocols. Served QC Analytical SME focused on addressing questions during regulatory compliance audits and supports inspection related needs. Provide oversight, technical guidance, support training, and mentor QC associates and other team members.
Preclinical and clinical assay development/ optimization/ qualification to support required testing of cell/gene therapies and viral vectors used in the manufacturing process. Drafted and revise SOP/test methods and provide life cycle management. Served as SME and QC representative supporting development of analytical methods for AD-QC method transfer, qualification, and execution support.
● Supported clinical testing and GMP regulatory release of 2 tumor infiltrating lymphocyte (TIL) based cell therapy products via flow cytometric methods. ● Develop novel analytical methods, oversee method transfer, and implement test methods for real-time in-process and final product release and disposition of cell therapy product. ● Draft and revise SOP/test methods and provide life cycle management. ● Provided direct management and day-to-day oversight of QC Sr. Analysts/Analysts, including hiring, 1-on-1 meetings, and career development. ● Serve as flow SME and QC representative supporting development of custom gating hierarchy profile for final product release on algorithm based AI gating platform. ● Conduct OOS investigations, lab investigations, deviations, change controls, and protocol exceptions during support of clinical trial manufacturing. ● Perform lab supply inventory and critical materials management for QC analytical related testing and operational function.
● Performed characterization and analysis of CAR transduced T-cells (functional analysis, fitness, phenotype) for product registrational support of KTE-C19/X19 across all ongoing and active clinical trials. ● Conducted flow cytometric analysis of longitudinal biospecimen sampling (PBMC, bone marrow aspirates, cerebral spinal fluid) time points from patient subjects across all ongoing CD19 CAR clinical trials, Yescarta, and Tecartus related products. ● Supported exploratory research for expanded programs, pipeline research, scientific collaborators, and European Union expansion. ● Managed external vendors and key technology platforms with emphasis on flow cytometric based assays. ● Provided support for PK and PD immunological assays, including MSD, Luminex, and ddPCR. ● Validated flow cytometry test methods, developed SOPs, and adhered to GLP/GXP processes and procedures in accordance with industry standards.