Gary Dykstra Integrated Material Sciences LLC (Principal) 2665 N Atlantic Avenue Suite 118 Daytona Beach Florida 32118 Company Website Email Gary@IMSLLC.net Phone 845-728-2001 Professional Summary Highly experienced Validation Chemist and Analytical Consultant with over two decades of expertise in method development, validation, regulatory compliance, and laboratory operations. A proven leader in chromatography (HPLC, GC-MS, AA), formulation chemistry, and GMP documentation. Adept at transitioning companies to in-house analytical testing and optimizing laboratory workflows for efficiency and compliance. Extensive background in the pharmaceutical, nutraceutical, petrochemical, and materials science industries. Core Competencies Equipment Acquisition and Qualification Method Development & Validation Process Design, Qualification and Verification High-Performance Liquid Chromatography (HPLC) Gas Chromatography (GC-MS, GC-FID) FAAS/ICP/UV/IR Spectroscopy Titrations GMP, FDA, ISO Compliance OOS, Root cause, CAPA, Revision Change Organic, Kosher, and Halal Certification SOP Development & Laboratory Documentation Equipment Acquisition & Laboratory Setup R&D, Pilot Formulation Product Stability Environmental Monitoring Compounding API, USP, And Inactive Ingredients Vendor Qualification Project Management Agilent OpenLab, ChemStation, and MassHunter Waters Empower and Perkin elmer totalchrom Empower (Waters) & LIMS Systems Inventory Management Systems Excel, JMP, Minitab and Access Sample Preparation & Extraction Techniques Thermal Decomposition & Metal Digestion CFR ISO OSHA EPA FDA USDA USP European Pharmacopoeia Compliance Quality by Design (QbD) – CQAs, risk, process control, improvement Phase 1-4 FDA Clinical trials Key Qualifications Multidisciplinary Troubleshooting & Technical Skills — Proficient in diagnosing and resolving complex issues across laboratory, industrial, and facility systems. Practical expertise spans plumbing, electrical, carpentry, and structural engineering principles, with working knowledge of code compliance to ensure safe and regulatory-aligned modifications. Skilled in welding, fabrication, and CNC design, related to tooling fabrication and troubleshooting bridging hands-on craftsmanship with technical precision. This breadth enables rapid response to mechanical failures, infrastructure challenges, and equipment design needs, reducing downtime and enhancing operational resilience. Food Safety & Quality Systems Leadership – GMP, FDA, FSMA, HACCP, FSSC 22000, ISO 9001/14001/45001 Regulatory Compliance & Audit Management – FDA, EPA, ISO, Kosher/Halal, internal & external audits Budget & Capital Planning – laboratory buildouts, equipment acquisition, cost control, continuous improvement savings ($150K+ /yr perpetuity scaling annually) Environmental Health & Safety – EPA compliance, ISO 14001 monitoring, environmental controls in chemical, Pharma & nutraceutical operations Team Leadership & Development – built and managed high-performing QC and R&D teams; trained and mentored scientists and engineers Continuous Improvement – transitioned outsourcing to in-house labs, optimized workflows, GMP process enhancements ERP & Data Integrity Systems – LIMS, Empower, OpenLab, documentation control, master data governance transferable to SAP Cross-Functional & Executive Communication – direct liaison with regulators, C-suite, and external auditors on compliance and technical operations Leadership & Cross Functional Oversight Hired, supervised, trained, and qualified multidisciplinary teams across Manufacturing, Quality Control, Quality Assurance, and Raw Material Purchasing, ensuring alignment with GMP, ISO, and corporate standards. Built a culture of compliance and continuous improvement by developing staff capabilities, standardizing qualification processes, and leading audit-ready operations. Technical & Creative Systems Support 20+ Years of graphic arts design, product packaging and Adobe creative could applications Applied a minor in Liberal Arts to enhance professional roles beyond chemistry, including document control, technical writing, marketing collateral, and incident (INCI) design. Designed and supported web hosting and digital documentation systems for laboratory operations, improving accessibility, regulatory compliance, and cross-departmental communication. Professional Experience Founder & Principal Integrated Material Sciences LLC | 2024 – Present Daytona Beach, Florida Provide consulting services for method development, validation, and regulatory compliance for pharmaceutical, Industrial and Research in a diverse portfolio of consumer Healthcare and manufacturing services. Assist companies in transitioning from outsourced testing to in-house analytical capabilities, optimizing workflows, and acquiring appropriate laboratory equipment. Develop GMP-compliant documentation, including SOPs, validation reports, and regulatory compliance Specialize in chromatography and elemental analysis techniques, troubleshooting complex analytical challenges. Validation Chemist & Scientific Consultant Redacted NDA | 2022 – 2025 Holly Hill, FL Designed and validated analytical methods for pharmaceutical products, including sunscreens, vitamins, and formulations containing zinc oxide and titanium dioxide. Performed instrument qualifications (IQ/OQ/PQ) and preventive maintenance for Agilent HPLC systems. Assisted laboratories with compliance documentation and data integrity improvements. Provided statistical analysis and research support for method optimization. Analytical Consultant R&D Chemist Beach Grove Technologies | 2015 – 2019 Hopewell Junction, NY Senior Chemist II Watson Pharmaceuticals (Teva) | 2008 - 2014 Conducted HPLC, GC-MS, and GC-FID assays for raw materials, in-process, and finished pharmaceutical products. Managed analytical method validation and verification for prescription (RX) and OTC drug products. Led quality control initiatives, authored Certificates of Analysis, and ensured regulatory compliance. Trained junior chemists in advanced analytical techniques and GMP regulations. Quality Control Manager Pharmline Inc. (Stauber) | 2001 - 2008 Hired managed trained 10+ Technicians and Quality Assurance Personal Developed and validated new analytical assays for pharmaceutical and nutraceutical products. Authored and revised SOPs, ensuring full compliance with FDA and CGMP standards. Led research and development projects for new formulations and product enhancements. Served as the QC department representative during regulatory audits and compliance reviews. Analytical Chemist I Revere Smelting and Refining | 2000 - 2001 - Contract Position Middletown, NY Analyzed and processed metal samples using ICP and XRF Conducted environmental compliance testing and ensured adherence to EPA regulations. Assisted in battery recycling and smelting operations, analyzing lead and heavy metal content. R&D Chemist Pfizer Global Research and Development | 1999-2000 Contract Position Morris Plains, NJ R&D formulation for Drug discovery Phase I and II clinical trial support for Geodon® Disolution bioavailability testing MIC / Micro testing for new API anti microbials Synthetic Chemist / Formulation Chemist Westwood Chemical Corporation | 1998 - 1999 Performed synthesis and formulation research for specialty chemicals. Conducted wet chemistry analysis, including gravimetric, volumetric, and titration methods. Utilized analytical instrumentation such as IR spectroscopy, HPLC, and GC. Education & Certifications State University of New York at New Paltz Bachelor’s Degree in Chemistry | 1997 - 2002 Professional Training & Certifications: American Chemical Society (ACS) approved Bachelors Program Liberal Arts minor Additional Information Extensive experience with method development for sunscreens, vitamins, and formulations containing metallic oxides. Special expertise in regulatory compliance and forensic documentation for legal and audit purposes. Passionate about mentoring and training professionals in advanced analytical techniques.