Description
relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with quality control of biologics /cell therapies * Team player, with experience in interdepartmental communications with MF, analytical QC/QA and QC departmental organizational flow. * Responsible for final product release package compilation and sign-off * Perform QC liquid nitrogen inventory management. * Responsible for analytical test documentation, review and compilation of product release package for submission and resubmission to QA. * Maintaining trending spreadsheets/files * Stay apprised of changes to assays, Nonconformance, CAPA, OOS or other procedures or documentation requests from QA. * QC Lead for internal and weekly internal planning and client meetings for Nonconformances, CAPAs and OOSs. * Subject Matter Expert for drafting OOSs and Nonconformances for QC Analytical. * QC Lead for tracking Nonconformances, OOSs and CAPAs and ensuring their closures in a timely manner. * Leads and interacts internally and externally with clients in order to close Nonconformances, OOSs and CAPAs. * Lead for daily updating QA and QC Analytical trackers with progress on Nonconformances, OOSs and CAPAs. * Lead and assign OOSs and Nonconformances to two technical writers. * Responsible for shipping Manufacturing's vialed particulates to McCrone. * Draft memos for McCrone results in order for product to be dispositioned. * Report internal weekly and monthly metrics for OOSs. Oxford Diagnostics Laboratories Senior Scientist, Development, 04/2013 - 03/2016 Concurrently established the tissue culture facility at the Oxford's Memphis site while supervising the team developed the new laboratory derived test for transplant rejection detection. Spearheaded the task of reproducing and validating the novel test established by the R&D team. Executed continuous improvements, significantly raising quality standards for discovery, identification, and development of cost-effective solutions. * Launched a feasibility study of a novel test with clinical applications for transplant patients. * Ensured good GDP within the GLP development lab on maintaining laboratory notebooks and batch records * Oversaw the validation work on new equipment and equipment monitoring * Prepare validation protocols and reports for submission to Quality department. * Functioned as Project manager for the new Laboratory Developed Test, developed from my feasibility study * Develop SOPs for new processes. * Played major role in the development of other diagnostic tests of interests to the company. GTx Inc. Senior Research Associate, Drug Discovery, 10/2007 - 12/2009 and 6/2012 - 3/2013 * Conducted in vitro studies examining the molecular and pre-clinical pharmacology of proprietary drug candidates while ensuring compliance with GLP and other regulatory guidelines. * Prepared technical reports, summaries, protocols and/or quantitative analysis ensuring accurate documentation of scientific contributions in accordance with established operating procedures. * Performed routine instrument and laboratory maintenance. * Mentored and provided training and guidance in proper laboratory techniques to new personnel in the laboratory. * Provided research support in various cell-based and molecular pharmacology assays leading to the discovery of new drugs in my pre-clinical discovery group. * Provided support in identifying the mechanism of action of various selective receptor modulators. St. Jude Children's Research Hospital, Senior Research Technologist, 06/1999 - 10/2007 Biochemical elucidation of the unknown properties and functions of the MDM2 protein. * Identified and published a new role for MDM2 protein. The oncogene MDM2 is known to promote tumor growth however, my research for the very first time showed that depending on the signal MDM2 can have inhibitory properties. * Promoted from Research Technologist to Senior Research Technologist February 2000.
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