Samuel H. Hatcher

Founder of multi-faceted consulting business delivering compliance remediation, due diligence, and operational optimization for FDA-regulated manufacturers in the medical device, pharmaceutical, and OTC-drug sectors. Focusing on value-added projects and partnering with client executives and managers to implement ISO 13485 and cGMP improvements resulting in measurable gains in FDA audit readiness and process efficiency.

Co-founder and CEO of Rustic Deco Incorporated. Rustic Deco designs and manufactures unique furniture and décor, specializing in rustic and industrial styles for home office, dining and entertainment areas.

Sr. Vice President responsible for Operations, Product Development and Quality at Scapa Healthcare.

Operations leader for Knoxville, TN and Inglewood, CA facilities. Scapa Healthcare is a strategic outsource partner of skin friendly turn-key solutions for the global healthcare industry. Scapa Healthcare partners with market leaders to design, develop, manufacture and commercialize innovative medical device products. Scapa Healthcare operates within three market segments: Advanced Wound Care, Consumer Wellness and Wearable Medical Device markets.

Global lead for Healthcare Quality and Regulatory organization. Responsible for ongoing review, strategy development and operational planning to ensure that all quality assurance programs and systems meet current standards and applicable regulations.

Reporting directly to the BU CEO and accountable for Quality Assurance and Regulatory Affairs for the world’s largest producer of Positron Emission Tomography (PET) Drugs covering 51 radiopharmaceutical manufacturing sites globally, including sites in United States, France, UK, India, and Korea. Within Siemens, PETNET Solutions is a leading company in the business of manufacturing and distributing radiopharmaceuticals, including radiopharmaceuticals used for Positron Emission Tomography (PET) imaging.

Global lead for Quality Assurance, Quality Control, and Quality Engineering for five internal and numerous contract manufacturing sites producing Playtex products, including oversight for a diverse portfolio of product categories from medical devices to OTC-drugs, to personal care products. Strategically deployed organization-wide quality-system initiatives designed to enhance cGMP compliance for brands such as Banana Boat, Hawaiian Tropics, Diaper Genie, Wet Ones (anti-bacterial wipes), Playtex Gloves, Playtex Tampons, and Playtex Infant Care Products.

Reporting to Division President, responsible for Technical Operations, Quality and Regulatory for three manufacturing facilities (>1400 employees). - Managed technical and quality relationships for all primary accounts, including Johnson and Johnson, Proctor and Gamble, Burt’s Bees, L’Oreal, Elizabeth Arden and Playtex (Energizer Personal Care). - Formulation/Compounding, microbial-risk management and analytical-testing Subject-Matter-Expert for the company. - Promoted from single-site Technical Director to multi-site Vice President.

As part of a global team, I worked to ensure effective quality management and technical oversight of outside contract manufactures and service (GMP and GLP) providers - including ICH stability service providers and testing facilities. Hosted regulatory audits (FDA and MHRA) and monitored technical compliance of the on-site pharmaceutical sterile manufacturing facility.

Led analytical development, validations and protocol (IQ/OQ/PQ) generation/execution/closure for the Augusta API manufacturing site. Worked as backup lab supervisor, and led complicated OOS investigations. Optimized GC and HPLC test methods for PAI (new) products. Worked to transfer technical knowledge from other Pfizer sites and R&D. Promoted to Principal Scientist.

Optimatization of analytical testing and manufacturing processing for API (drug substance) facility. Worked to develop analytical tests and methodologies to validate change-over cleaning for equipment used to manufacture pharmaceuticals. Performed lab-scale organic synthesis to evaluate and improve manufacturing performance.

Performed and developed HPLC, GC, AA and CZE tests for in-process and finished goods for API manufacturing site. Highly trained in HPLC and GC troubleshooting. Aided in OOS investigations where needed. Authored laboratory and manufacturing OOS investigative reports as needed. Promoted to Scientist.

Performed USP, BP and JP monograph testing for APIs. Also performed TLC, titrations, particle size analysis, IR, UV-Vis and other testing for drug substances. Promoted to Chemist.

Part-time and Full-time while in collage. Worked under guidance of a Certified Medical Lab Tech to perform routine medical bioanalysis, microscopy and instrument calibration.

Concentration in Systems Engineering

Complete as of January 2011. Certification consists of seven-months of course work and several hands-on projects. The elements of the program covered advanced Lean Six Sigma methodology and statistics, Accounting/Finance associated with project management and Strategic Leadership.

General Business

I transferred/relocated for job-related reasons before completing the program.

3.9 GPA for double major... Who's Who Among Universities and Colleges (1997) (GRU was previously named Augusta State University (ASU)