Gary Chilson Email & Phone Number

Los Angeles County, California, United States

Cave Creek, Az

Providing quality systems, regulatory, and process improvement consulting for drug, medical device, personal care, dietary supplement, and food manufacturers and distributors including:-Gap analyses-Onsite audits and training-QMS setup including SOP creation and process implementation -Label and formula reviews-Regulatory compliance consultation, review, and registration-Project Management-Process improvement

Scottsdale, Arizona

Led operations for a personal care contract manufacturer including:-Product Development & Project Onboarding-Customer Service and Sourcing -Graphic Arts -Quality & Regulatory-Production-Warehouse & Logistics

Scottsdale, Arizona

Chandler, Arizona

-Led a team of 27 scientists and technicians in a high volume and high paced lab performing quality release testing and method development for nutritional supplements in compliance with 21 CFR part 111.-Capabilities included microbiology, HPLC, HTLC, IR, and ICP/GC-MS-Drove all laboratory continuous improvement and lean six sigma projects leading to an increase in lab OTD of over 35%-Member of site continuous improvement team

Rochester, Ny

-Led a team of QC microbiologists supporting two site laboratories manufacturing human and animal probiotics-Team Champion for the Dupont Production System implementation team-Member of Six Sigma implementation and site continuous improvement teams-Developed all quality COT and KPIs-Led contamination incident investigations leading to a 25% increase in FPFQ -Led CCP and oPRP validations for CIP, SIP, COP -ISO 9001 and 22000 internal auditor-Leading member of site employee event planning committee

Rush, Ny

-Managed and conducted various USP, EP, and ISO microbial assays including: antimicrobial efficacy testing, zone of inhibition assays, minimum effective concentration, environmental monitoring, bioburden, sterility, and D value testing -Conducted gamma, EtO, and steam sterilization validations and product packaging qualifications-Responsible for meeting sales and customer service goals while maintaining high quality standards

Rochester, Ny

-Managed memorabilia, custom embroidery, and high-end military watch retail business.

Rochester, Ny

-Supported solution and lens manufacturing areas performing USP and FDA antimicrobial efficacy, biocidal, and regimen testing on contact lens solutions

Rochester, Ny

-Supported assay development of PCR diagnostic tests for oncological K-ras mutations, HIV-DNA and RNA, Cytomegalovirus, Hepatitis C Virus, Mycobacterium tuberculosis, and Mycobacterium avium complex assays-Performed various nucleic acid lab procedures including DNA isolation, enzyme analysis, cell culture, extensive PCR reactions (including REMS and ARMS), primer design, restriction site mapping, patent searches, radio-labeled analysis, agarose electrophoresis, oligo-nucleotide detection, and antibody antigen reactions-Co-Invented method of DNA extraction from paraffin embedded tissue using a thermophilic protease and heat (Patented in US and Europe)-Worked on publication with University of Rochester for early detection of colorectal cancer using the K-ras marker in Duke’s B colon tissue samples

Bachelor Of Science (Bs), Microbiology

Associate Of Arts And Sciences (Aas), Biotechnology