Food Safety Manager
Resume:
SHAWN CHARLES
Sparta, NJ *****
*****.*********@*****.***
PROFILE
Analytical Chemist working in Pre-Clinical Drug Safety and Metabolism – Pharmacokinetics: managed multiple projects and delivered data on time in support of drug discovery, preclinical, clinical and toxicology studies.
Aided in design, and support of pharmacokinetic, metabolism (ADME), and residue programs resulting in successful registrations of small molecule pharmaceuticals.
Studies performed under GLP guidelines. Interact with regulatory agencies (FDA), QC/QA to ensure compliance with internal SOP's and GLP guidelines.
Analytical chromatographic and extraction methods development, validation and sample analysis, with quantitation by LC/MS/MS to support pharmacokinetic, toxicokinetic, clinical efficacy and/or human food safety studies in a GLP environment.
Compiling data and writing final reports for FDA submission.
Setting up instrument analysis, and processing and interpreting LC-MS/MS data.
EXPERIENCE
Scientist 2010-2019
Global Preclinical Development - Bioanalytical USA
Merck, Rahway, NJ
●Numerous successful product registrations for major products such as Bravecto, Florfenicol and Emamectin.
●Implemented an automated report writing tool to extract data from Watson LIMS to Microsoft Word, increased efficiency of writing and tabulating analytical reports by 75%.
●Developed universal laboratory robotic instrumentation software program for liquid handler (Hamilton) to increase precision, accuracy and productivity by 50% for entire department.
●Accomplished multiple assay method validations for tissue residue methods which gained approval by FDA/CVM reviewers.
●Development, validation, and analysis of biological samples using automated analytical methods for the quantitation of drug candidates in biological matrices by LC-MS/MS (Sciex) and HPLC UV (Waters, Agilent).
●Manage and oversee bioanalytical studies at external providers in support of preclinical programs. Responsibilities include design of protocols, placing studies at CRO’s, site visits for critical phase audits, sample management and data/report review.
●Assured GLP compliance as PI by prompt accurate data recording in notebook and ELN.
Scientist I 2000-2010
Department of Drug Safety and Metabolism – Animal Health
Schering Plough Research Institute, Lafayette & Summit, NJ
●As a bioanalytical chemist assumed the responsibilities associated with the development and validation of regulatory methods that are used for routine sample analysis for drugs in animal tissues and plasma.
●As Study Director/Analytical Investigator, responsible for all study activities from protocol development to final report preparation for both in-house and studies conducted at CRO’s.
●Ensured the GLP compliance of instrumentation (IQ/OQ/PQ) and all study related activities under strict GLP compliance and regulatory (FDA CDER & EU) guidelines.
●Tissue and plasma drug residue analysis techniques, radiotracer experimentation and the analysis of radiolabeled drug residues in animal tissues.
●Formulation of dose solutions and dose concentration confirmations.
●Sample extraction and cleanup of biological samples (i.e. plasma and tissues) using automated instrumentation (i.e. Hamilton MicroLab STAR & Tomtec), PPT, LLE, SPE in 96-well format. Troubleshooting analytical instrument problems.
●Prepared CRO contracts, obtained competitive price quotes, site qualifications, facility visits, monitoring in-life dosing, sample collection, writing trip reports, reviewing CRO study data and final reports.
SKILLS
Bioanalytical /Pharmacokinetics
●Data and sample management using Watson LIMS.
●MS/MS: Applied Biosystems –Sciex (Analyst), Thermo Scientific TSQ Vantage, Thermo Finnigan Quantum, LCQ Deca (ion trap), and Micromass Quattro Ultima.
●HPLC’s: Agilent, Waters, Perkin Elmer and Leap systems.
●GC, GC-MSD (Hewlett Packard).
●Maintain, repair, clean and troubleshooting of instruments.
Other Related Research Experience
Toxicology: Preparation and administration of various dosing regimens, daily observations of study animals and assisting with necropsy
EDUCATION Master of Science Animal Science (Metabolism)
University of Tennessee, Knoxville, TN
Bachelor of Science Animal Science / Business Minor
Delaware Valley College of Science & Agriculture, Doylestown, PA
Continuing Education, MBA, Pharmaceutical Sciences, Fairleigh Dickinson University, Madison, NJ (degree not earned)
PROFESSIONAL MEMBERSHIPS American Society of Mass Spectrometry
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