Jeffrey Bolts, Ph.D.

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Senior Quality Consultant

Jeff has over 25 years of experience in research and development, quality assurance, and regulatory and clinical affairs in the medical device, biotechnology, pharmaceutical and chemical industries. As a former Director of Quality Assurance for a Fortune 100 biomedical company, Jeff has broad expertise in all aspects of quality systems implementation and improvement, as well as practical experience in achieving quality imperatives within the day-to-day constraints of the manufacturing environment. A former research scientist and manager, Jeff also has special expertise in design control, in product research and development, and in technology assessment and transfer.

 

EXPERIENCE…
  • Participant on the Production & Process Control and Design Control teams whose efforts contributed to significant quality system improvements and ultimately the Abbott Laboratories diagnostic division being found in substantial compliance in the successful response to FDA consent decree.
  • Participated in Design Control review and remediation team for a leading drug coated stent device.
  • Consultant to a diverse mix of large, industry-leading corporations and small, development-stage companies, including Abbott Laboratories, Cordis – Johnson & Johnson, Ixion Biotechnology, Imaging Diagnostic Systems, and Genetic Vectors.   Expert in quality systems implementation and enhancement, product research and development, and in regulatory compliance.
  • Directed QA staff of 40 supporting $500MM immunochemistry, clinical chemistry, hemostasis and controls businesses.   Responsibilities included day-to-day support of manufacturing operations, compliance audits, design control, process validation, supplier audits, documentation systems, corrective/preventive actions, and instrument/software QA
  • Led process improvement team that halved production time and tripled yield of a recombinant human protein.
  • Improved turnaround times for QC testing from days to hours, while reducing laboratory staffing by 1/3.
  • Received Baxter Quality/Regulatory “Person of the Year” award.
  • Received “Extra Effort” award for development of the Troponin-I cardiac immunoassay.
  • Managed R&D laboratory for analytical method development and validation of new bioanalytical techniques.
  • Responsible for R&D, clinical trials and 510(k) filings for various home-testing and professional-use diagnostic products.
  • Led R&D team that developed the first real-time immunosensor system for battlefield detection of pathogenic bacteria and viruses. Project success led NATO allies to join US Army development program.
  • Managed 10 scientists in development of fiber optic, electrochemical, acoustic and nucleic acid biosensors.
  • Experienced in government contract research, subcontractor coordination, and new technology evaluation.
POSITIONS HELD…
  • Senior Quality Consultant – BioTeknica, Inc.
  • Director of QA/RA & Acting Director of R&D – Technical Chemical Products, Inc.
  • Director of Quality Assurance – Baxter Diagnostics (Dade-Behring), Inc.
  • Manager of Reagent Quality Assurance – Baxter Diagnostics (Dade-Behring), Inc.
  • Manager of Research and Development – Baxter Diagnostics (Dade-Behring), Inc.
  • Group Leader – Allied-Signal, Inc.
  • Senior Research Chemist – Allied-Signal, Inc.
  • Research Chemist – Allied-Signal, Inc.
EDUCATION…
  • Ph.D., Physical Chemistry – Massachusetts Institute of Technology
  • A.B., Chemistry – Princeton University