Scientist Ii

• Jan 2022 - Present

Scientist 2

• Jan 2022 - Present

Biotin Mitigation Immunoassay Development

Scientist 1

• Feb 2017 - Dec 2021

• IVD clinical verification data analysis on interfering substances for β-hCG, CEA, Prolactin and AFP• Principal role conducting VITROS® B•R•A•H•M•S PCT (Procalcitonin) clinical verification experiments including: Linearity, Limit of Detection (LOBDQ), High Sample Dilution, Spike Recovery and Sample Carry-Over • Comprehensive data management and analysis per CLSI guidelines using Minitab and Microsoft Excel with Analyse-it, including dose-response statistical analysis for Weighted/Non-Weighted Linear Regression, Mean, SD, % CV, % Bias, % Recovery• Method Comparison using Passing-Bablok and Deming regressions• IVD assay development for VITROS® B•R•A•H•M•S PCT (Procalcitonin); earning FDA 510(k) in February 2020 • Author of final reports• Process improvement and 5S laboratory management • Verification and validation of VITROS® XT 7600 and XT 3400 IVD analyzer systems Show less

Microbiologist - RM (NRCM)

• Jun 2010 - Dec 2016

• National Registry of Certified Microbiologists in Pharmaceutical and Medical Device Microbiology • Established robust testing methodologies: Principal development of microbial aerosol challenge test of medical device packaging systems; test method is FDA approved and ISO 17025 accredited • Medical Device validation testing for Sterility Assurance, Dry Time, Biocompatibility (ISO 10993), Cleaning/High Level Disinfection, Product Life Cycle • Validation of new processes, procedures and equipment • Study Director for Packaging Systems - led technical reviews for Protocols, Reports and Controlled Documentation • Technical Writing and Document Change Control • Interpreted research findings and summarized data into reports • On-site validation testing • Project Management, CAPA’s, Root Cause Analysis • Aseptic Technique, Assays, D-Values, Biocompatibility Testing, Protein Analysis • AAMI/ISO/AORN Testing • FDA (21 CFR Part 820) and ISO 13485 Quality System Regulations for Medical Devices • Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) • Creation and Implementation of Standard Operation Procedures • Environmental Monitoring and Equipment Calibration • New Staff Development and Training • 510(k) Pre-Market Approvals • Supply Chain Procurement and Inventory Management • Good Documentation Practice (GDP)/Good Laboratory Practice (GLP) Show less

Live Materials Technician

• 2007 - 2010

• Microbiologist lead for the laboratory • Commercial culture of bacteria, fungi, protists and algae • Manufacture of lyophilized specimens and microbiological media • Production of bio-technology kits • Animal husbandry of invertebrates and vertebrates • Microbiologist lead for the laboratory • Commercial culture of bacteria, fungi, protists and algae • Manufacture of lyophilized specimens and microbiological media • Production of bio-technology kits • Animal husbandry of invertebrates and vertebrates

Quality Technician

• 2007 - 2007

• Audit production of food products, including glazes, pie fillings and frostings used in bakery items • Ensured compliance of GMP protocols • Quality control of raw materials and finished goods • Lab management and calibration of all testing equipment • Audit production of food products, including glazes, pie fillings and frostings used in bakery items • Ensured compliance of GMP protocols • Quality control of raw materials and finished goods • Lab management and calibration of all testing equipment