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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLEStreet Address
PHONE NUMBER AVAILABLEEDUCATIONUniversity of Missouri, Columbia MOBachelor of Science in Biomedical Engineering and Medicinal ChemistryMinor in MathematicsGraduation: Dec 2013EXECUTIVE SUMMARY:Biomedical and Chemistry Professional with proficiency in pharmaceuticalEXPERIENCEPfizer Inc. Andover, MA January 2023 Present.Lab Automation and Instrumentation Scientist, Analytical Research and Development.Responsible for routine maintenance, calibration coordination of repairs and troubleshooting of all liquid handler instruments i.e., Hamilton Star, Hamilton Starlet, Tecan, Agilent Bravo and Integra Assist Plus.Implements and Identifies hardware and automated control software to improve the automation infrastructure i.e., Venuss software, VWorks software and Vialab Software.Focuses on identifying, developing, and implementing strategies to increase the scalability and efficiency of workflows performed within the Pfizer Andover Research and development laboratory.Develops new automation workflows to support the R&D team in their routine use and troubleshooting of existing automation. Works with a wide range of cutting-edge automation technologies while in a dynamic and cross-functional team.Translates, customizes, and validates wet lab bioassays into liquid handler systems as well as assists with experiments in the lab. Helps generate data to support modeling, submitting, and executing models on workstations and high-performance clusters, post-processing and analyzing the data generated from models.Participates in the design of efficient end-to-end automated solutions within the R&D digital group. Engages with vendors and coordinates end-user requirements of robotic systems, delivery, installation, and testing.Author, review and oversees the preparation of regulated documents for equipment qualification and SOPs. Perform job responsibilities in compliance with cGxP and all other regulatory agency requirementsPfizer Inc. Andover, MA March 2021 January 2023.Quality Control Analytical Scientist II Tech Transfer.Primarily responsible for the validation, verification, and transfer of bioprocess for all small molecule drugs and biologic drugs analytical methods. Within the Quality Control Analytical Department has expertise in SOP writing, validation protocol writing, execution, finalization of validation reports, as well as updating any associated and applicable specification documents.Analyzes testing in compliance with applicable quality systems and to meet site needs. This includes proficiencies in chromatography especially UPLC and HPLC for methods using SEC, RP, IEX, SDS-CGE, ICIEF, CIEX, Molecular and Peptide mapping.Responsible for automated and Manual Titrations, pH meter testing, UV-Vis, Solo VPE, Osmometer and with the use of Empower 3, NuGenesis 8.0, Karat, Chromperfect, PDOCs and LIMS for data analysis. Isolator trained and Control Drug Analysis proficient.Ensures that laboratory productivity and turnaround goals are met through timely completion and technical reviews of laboratory testing. Serves as subject matter expert when involved in qualification or validation activities and governing site SOPs.Diligently works to ensure that laboratory equipment and supplies are maintained in such a way that laboratory productivity and customer service needs are not impacted.Safeguards laboratory systems, SOP and ensures that a better understanding that facilitates efficient laboratory operation.Tests all samples in accordance with written procedures, reviews laboratory data for compliance to cGMP and cGLP and works cooperatively in a team environment.Maintains strong knowledge and experience testing, analyzing small molecules, raw materials, problem solving, data analysis and problem solving as well as equipment maintenance and trouble shooting.Pfizer Inc. Rocky Mount, NC February 2016 March 2021.Senior QC Specialist, Method Development and Validation.Primarily was responsible for development, validation, verification, and transfer of analytical methods within the Chemical Quality Control Department. Including validation protocol writing, execution, finalization of validation reports, as well as updating any associated and applicable documents.Analyzed testing in compliance with applicable quality systems and to meet site needs. This includes analysis on HPLC, UPLC, Automated and Manual Titrations, pH meter testing, UV-Vis, Osmometer, Polarimeter, and with the use of Empower 3, NuGenesis 8.0, ThermoLIMS and gLIMS for data analysis. Isolator trained and CDA proficient.Ensured that laboratory productivity and turnaround goals are met through timely completion and technical reviews of laboratory testing. Served as subject matter expert when involved in qualification or validation activities and governing site SOPs.Safeguarded laboratory systems, SOP and ensured that a better understanding that facilitates efficient laboratory operation.Pfizer Inc. Rocky Mount, NC February 2016 March 2021.Senior QC Specialist, Method Development and Validation.Master Data Builder gLIMS.Assisted in updating LIMS and corresponding departmental SOP and training materials as needed in accordance with LIMS global procedures. Tested all builds in Application Lifecycle Management Quality Center prior to approval for site use.Created, processed, modified and updated Master Data and ensured all sample management, laboratory systems as well as electronic systems were properly interfaced with LIMS in accordance with the Rocky Mount site per global procedures.Offered troubleshooting expertise and support for all LIMS all user levels and developed training modules/protocols/walk-through guides accordingly.Diligently worked to ensure that laboratory equipment and supplies are maintained in such a way that laboratory productivity and customer service needs are not impacted.Tested all samples in accordance with written procedures, reviews laboratory data for compliance to cGMP and cGLP and works cooperatively in a team environment.Maintains strong knowledge and experience testing, analyzing small molecules, raw materials, problem solving, data analysis & problem solving as well as equipment maintenance and trouble shooting.LabCorp Burlington, NC (Flex Schedule) June 2015 February 2016Lab Technologist, Radio Immunoassay DepartmentFollowed all standard operating procedures, safety and security polices and prescribed GLP and Biomarker and Immuno-analytical division practices, policies, and guidelines, using SOP manual as reference to job duties.Performed validation and sample analysis assays for HCC (Hepatocellular Carcinoma) and bone metabolism and bone absorption indicators from biological samples. Sent resulted instrument data from patient testing using GMRE, GAMMA and Vitros programs. In accordance to provided procedures, practices as well as project directives also set up and ran glucagon testing for pancreatic tumor indicators and hypoglycemia.Maintained and ran advanced technologies of various cell-based assays and trained on Elisa (including but not limited to technologies such as: Tecan system; Micro Beta Counter; Ortho ECI system: Apex Counter; Wako; robotics; automation; etc.) Performed daily, weekly, monthly, and quarterly maintenance on instrumentation. Performed minor repairs on instrumentation with the direction of service engineers or other trained supervisory personnel. Documented all maintenance, calibrations, and repairs as required.Prepared reagents, solutions, and QCs per procedure when needed to perform routine assignments and ran variations on tests.Properly used and maintained analytical equipment to accomplish work objectives (pipettes, rotators, centrifuges, plate washer, plate reader, balances, pH meter, etc.)Documented maintenance and calibration as required and maintained familiarity with all aspects of Apex Gamma Counter, used of the relevant modules and functions for the Biomarker and Immuno-analytical Division. Ran Tecan system and Micro Beta counter for hormone testing.Adecco- Nypro Mebane, NC (Flex Schedule) August 2015- January 2016Quality Assurance Lab Technician for Novo Nordisk, Healthcare DepartmentEnsured documentation and procedures were in compliance with Novo Nordisk specifications, Industry standards and standard operating procedures.Conducted start-ups and close-outs in accordance with inspection criteria and assisted with troubleshooting recurring defects and if necessary, utilized stated modifications and corrective actions for recurring or non-recurring discrepancies.Reviewed Statistical Process Control (SPC) data in Predisys and Flexenal. Maintained integrity of SPC data by correcting input errors for product release.Adecco- Nypro Mebane, NC (Flex Schedule) August 2015- January 2016Quality Assurance Lab Technician for Novo Nordisk, Healthcare DepartmentConducted sampling and testing in-process product, and finished product as defined by quality specifications.Inspected, measured, and tested parts for the Novo insulin and epinephrine pen in accordance with mold inspection records, product plan requirements or engineering sketches and planned and perform layout inspection, process capability measurements and in-process inspection measurements.Ensured all product and raw materials testing in completed in adherence to guidelines established in the QATM and quality system operating procedure.Precisely documented test results on quality control records and maintained records in accordance with department and company specifications.Supported all company safety and quality programs and initiatives.Aerotek-Trinity Biotech Kansas City, MO June 2014 September 2014Quality Control Chemist, QC DepartmentObtained great mechanical aptitude, troubleshooting and problem-solving skills while extensively running HPLC and GMS on Premier Hb9210 Analyzer, Tristat and Ultra diabetes diagnostic systems, also ran FTIR. And used Viscometer, Density Meter, Polarimeter, Osmometer, and UPLC.Performed reagent, column, calibrator, control, stability, and validation testing of product production, including instrument performance validation testing, USP/EPAssisted in testing, reviewing, processing data and completed required documentation for all QC processes, gained extensive training in cGMP and cGLPAssisted in support of all departmental processes and objectives and supported of overall operations, customer service, product quality, regulatory compliance, on-time shipping, customer satisfaction, business objectives and the testing of raw materialsGained experience and is well-versed in Microsoft office programs, E Doc, Labware, Batch Records, Trackwise.Adapted system for customer focus and work for customer satisfaction ensuring FDA regulations where followed.Lab AssistantExposure to Research for Science Students program.Engineered cell lines from specialized mice while monitoring the development and cure for Battens disease.Performed blind tests and cure tests on mice, with Martin L. Katz, PhD Professor of Ophthalmology, Director Campus Electron Microscopy Core Facility.Ran zebra fish breeding experiments with mutations and tested the develop of certain disease using different cell lines, Ran DNA and RNA tests on zebra fish cell lines to study neuronal migration in the brain (facial branchiomotor neurons.) with Annand Chandrasekhar, Associate Professor University of Missouri Department of Cell Biology.Lab AssistantExposure to Research for Science Students programCatalogued specimens and helped with the storage and upkeep also with data entry working for Gabor Forgacs (PI) at the University of Missouri-Columbia.Engineered cells and maintained tissue samples for the building of living structures of specific shape and functionality employing the technology of bio-printing, cardiac tissue for cushion fusion and limb bud formation using in vitro assays under variable physical conditions.. |
