Kurt Phinney Email & Phone Number

Sarasota, FL, US

Operations consultant with experience leading and managing Manufacturing, Quality, Research, Technology Transfer, and Engineering. Adept at developing the foundational structure necessary for new company growth and success and bringing organizations to the next level of operational efficiency and excellence.

Tampa, Florida, US

• Maintaining and improving the Operational infrastructure of a fast paced, fast growing healthcare company with many facets. Verséa is comprised of divisions in Medical Diagnostics, Agriculture Technology, and Wound.
• Headed regulatory and cultural modifications to obtain ISO certification in 2023 and set guidelines for approval.
• Implementation of Microsoft Dynamics Business Central ERP system.
• Modernized the IT infrastructure to meet compliance needs and company goals.
• Led logistics of moving into a new headquarters in Tampa, FL. Including staff, warehoused goods, equipment, permits, utilities, and leases.

Carlsbad, California, US

• Responsible for international operational performance and production in a high growth in-vitro diagnostic company, reporting to the CEO. Oversee all functions of Operations department to cover massive demands of.
• As a member of the Leadership Team, contributed to a successful IPO, raising $63 million AUD.
• Designed greenfield customized 32,000 ft2 facility with annual capacity of 100 million diagnostic tests while administering to architectural planning, contractors, and builders.
• Maintained consistent production despite port and customs delays, trucking strikes, and border closures.

• Vertically integrated diagnostic assay production and manufacturing while operating as RPS’s first Director of Manufacturing. Steered design and outfitting of RPS’s first GMP chemistry and LFIA production lab..
• Reduced cost of goods by 62% and shortened overall production time from 120 to 45 days.
• Held a key role in the sale of two product lines to Quidel for $14 million USD.
• Scaled production of the flagship FebriDx product to support ex-US demand.
• Led a team to enhance throughput and consistency, while readying the FebriDx for US FDA Clinical Trials.
• Sourced, trained, and mentored staff in poly/monoclonal and conjugation chemistry, manufacturing, & tech transfer departments.

Hiram, Ohio, US

• Executed all Quality functions for the state-of-the-art $600 Million (PA) production facility in adherence to new federal mandates for Food Safety Modernization Act.
• Complete overhaul of the Quality System to meet the most current demanding regulations.
• Guided the facility and staff through multiple USPHS, State, and FDA regulatory audits resulting in +96% compliance rating and zero 483 findings.

Westford, Massachusetts, US

Sr Project Manager guiding the implementation of the first FDA approved Cloud Based computing and storage system designed for the biomedical environment.

FLORIA biosystems with Bioinnovation SA. A multi-year five stage platform development program based on our patent position in fluorescent LFIA.Focusing on the use of fluorescent markers for LFIA using time-resolved fluorescence (TRF) techniques to enhance sensitivity and improve reproducibility, we demonstrated a 100X improvement in sensitivity compared to.

• Directed manufacturing and quality divisions through an extensive overhaul, increasing production yield by 70% with a concurrent drop in customer complaints by 85% over a span of three years.
• Designed a Quality Control program to insure manufacturing had tools necessary to identify deficiencies in real-time, reducing expenses related to later-stage production failures.
• Increased production awareness with Sales, VP and the CEO to deliver just-in-time manufacturing lessening materials cost and overhead.
• Employed FDA, TOC, ISO, & GxP standards to develop Regulatory Compliance plans and documentation.

• Lead manager guiding the manufacture of HIV, Lyme, Cysticercosis, and Miniblotter products (FDA approval and patents granted).
• Developed Immunoassays in ELISA and Western Blot formats with an eye towards large-scale production implementation.
• Developed, co-developed, and improved upon existing assays for of HIV, Lyme (human and canine), Cysticercosis, Anthrax and Hydatid.
• Led partner relationship with Harvard School of Public Health resulting in an exclusive contract to provide HIV testing in South Africa through the Bill and Melinda Gates Foundation.

HIV assay development, SARS and Anthrax testing protocols.

Washington, DC, US

Awarded Humanitarian Service Medal (twice) for Lifesaving Operations in Bering Sea, Outstanding Military Achievement Medal, Military Unit Commendation Medal for Operation Desert Storm, National Defense Service Medal for Operation Desert Shield/Desert Storm, Military Good Conduct Medal (twice), and Meritorious Team Commendation.

Biology, Biochemistry

Marine Biology