I am a detail oriented team player that utilizes strong organizational skills to lead multiple projects simultaneously. My goal is to utilize my 10+ years of Analytical expertise and passion for team management to lead a Quality Control group.
Overview
20
20
years of professional experience
Work History
Senior Scientist, Group Lead
KBI Biopharma, Inc.
11.2019 - Current
Analytical Formulation & Sciences
Manage and mentor a group of six to develop, qualify, and validate all analytical methodology simultaneously across three projects
Analytical Functional Area Lead (QC) both internally and externally for all our group’s projects
Support interdepartmental collaboration with QA, manufacturing, and process development, and cross our various KBI sites
Development & implementation of analytical methodology as needed for early-stage projects, with an emphasis on continuous improvements as the projects proceeds to later stages
Supported Process Characterization (PC), Process Performance Qualification (PPQ), and method validation for phase III/commercialization
Simultaneously managed several complex projects, meeting all pertinent QC deliverables on time
Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems
Research & Development Scientist II
KBI Biopharma
06.2016 - 11.2019
Project lead scientist with emphasis on protein characterization by Mass Spectrometry and refold development
Worked on a wide range of potential therapeutic compounds ranging from peptides, proteins, PEGylated proteins, antibodies, and RNA
Supported several areas within the company from early stage fermentation, refold development, upstream & downstream
Analytical support for early- & late-stage projects including LC/MS, ELISA, PCR, HPLC, CE-SDS.
Research & Development Scientist I
KBI Biopharma
03.2014 - 06.2016
Perform in-process analysis on various therapeutic proteins in a GMP and non-GMP setting
Analytical method development on a wide range of instrumentation including mass spectrometry and liquid chromatography
Assisted in various stability assays for Quality Control to aid in the new site start-up
Implemented a new high end q-TOF mass spectrometer, Synapt G2-Si, and developed state-of-the-art methodology for a wide range of clients
Protein Characterization Chemist
Merck Pharmaceuticals
03.2013 - 01.2014
Studied a wide range of peptides and proteins using liquid chromatography mass spectrometry
Characterization of various manufacturing processing steps via mass spec to understand impurities along the downstream processing
Assisted in all stages of process development using complementary instrumentation such as ion exchange, size exclusion, isoelectric focusing, ultra and high pressure chromatography
Worked simultaneously on multiple projects from insourced, to onsite, to overseas intercompany projects
Graduate Doctoral Student
University of Florida
01.2005 - 01.2012
Utilized EPR in collaboration with a NMR research group to characterize membrane bound proteins – surfactants
Determined mechanism of action of FDA approved respiratory distress
syndrome treatment
Strong background teaching biochemistry, organic, general, and graduate level electronics lab
Qualified in both Biochemistry and Analytical chemistry
Drug Metabolism Associate
Abbott Laboratories
01.2004 - 01.2005
Worked in both the In vivo and In vitro areas of small molecule drugs
Executed daily activities including drug inhibition assays, drug analysis, LC/MS/MS method development, radio labeled drug tracking
Followed drug accumulation throughout animals via isotope labeled drugs
Participated in an analytical team providing high throughput drug analysis on LC/MS/MS instruments
Drug Metabolism Intern
Abbott Laboratories Abbott
01.2004
Provided help on a study for determining the cause of certain drug-drug interactions in cytochrome P450s
Performed metabolic stability, half life, and enzyme kinetic studies
Worked extensively on LC/MS/MS
Education
PhD - Chemistry
University of Florida
BS - Chemistry, Mathematics
University of Wisconsin
Skills
CGMP expertise for biopharmaceutical manufacturing
Strong team leadership and mentoring abilities to maximize efficiencies across teams
Mass Spectrometry – peptide mapping, trypsin digest, proteomics, high throughput drug screening, small molecule, ADME pharmacokinetics, protein characterization, PEGylation profiling, intact mass analysis