Cecilia T. M.
Associate Director - Assay Development @Nkarta, Inc
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WORK HISTORY
Associate Director - Assay Development @Nkarta, Inc
US
EDUCATION
California State University - Dominguez Hill
Master's Degree, MSQA
University of California, Davis
Bachelor's degree
ABOUT CECILIA T. M.
Professional Profile: Dedicated, motivated, and highly accountable Sr. Scientist/Manager/Principal QC with more than 20 years of industrial experience in assay development in a GLP/GMP compliant environment. An enthusiastic team leader, who leads each project with a commitment to achieving timely goals. Highly experienced in biological, immunological, and microbiological methods, especially in assay development and implementation. Broad skill set includes managing an analytical lab, assay development, and method qualification/validation (including lot release and characterization), involving a wide array of bio-products (oncolytic virus, live virus vaccines, recombinant protein vaccines, recombinant proteins, and gene therapy), and devices. Top-tier performance ratings.1. Knowledge: GMP & cGLP guidelines, FDA, ICH, EMEA, MHRA regulations2. Assay Development: Cell-based Potency, Plaque, Cell-based Neutralization, Phenotype, TCID50, Host Cell Protein (HCP) by ELISA, Total protein, Microbiology, HPLC, Western Blot, PCR, residual DNA, Sequencing, Impurity3. Compliance: GMP/GLP/CCP Trainer, Document Control/SOPs Aegis Author, CAPAs/OOS/Deviation User, Investigation Lead, Method Validation/Tech Transfer/ IOQ /PQ for Automation Lead, QC Review for clinical data/lot release/reagent /instrument logbook Reviewer, Lab Auditor4. Collaboration: NanoImaging Service, Inc, MSD, Hamilton, GE, Charles River, Agilent Technologies, Gyros, Nikon, Antitope, interaction with the different departments within the companies
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