Industry Consultant


C level executive with a consistent track record of exceeding objectives. 
Influential leader in the growth of BioMimetic from four to over 100 employees. Key  leadership for a highly interdependent team: multiple product development and registration programs (US and OUS), multiple funding rounds, IPO, international operations, critical partnership and licensing deals, and acquisition. 

Completed product and process development, pivotal trial execution, supply chain qualification, regulatory filing/review/approval with a team of less than ten people for a combination device/biologic product in less than four years.

  • Seventeen years executive management experience
  • Corporate Leadership
  • Strategic Planning
  • Corporate Partnerships
  • Contracts and License Agreements
  • Commercialization
  • Financial Management 
  • Full Operational Responsibility
  • Collaborative, empowering style
  • Energetic motivator and influencer
  • Customer, market, quality, and results focused executive
  • Thirty two years of solid career advancement
  • Extremely broad background in device, drug, biologics, API, diagnostics, and combination products; pre-clinical development through routine commercial operations 

Professional Experience:


BioMimetic Therapeutics, LLC. 09/02 – Present

Retained Consultant 04/14 – Present

Biological Devices/Protein Therapeutics/Combination Products

Continued in COO role as retained consultant to drive critical strategic initiatives: technology transfers, multiple pivotal license and supply agreement negotiations, critical compliance programs, pre-approval inspections, and commercial launches


SVP Operations/COO 09/02 – 04/14

Functioned as COO since 2010 - 2014; led operations and quality functions: entire supply chain, quality assurance, engineering, quality control, IT, customer service, and facilities operations.

  • Key leader on executive team: corporate strategy, growth from 4 to 100 employees, multiple regulatory approvals, international operations. Achieved US regulatory approval for a combination device/biologic product starting from phase 1 clinical in four years with a team of less than ten people
  • Led multiple product development programs and commercialization teams to exceed product launch targets and commercial supply goals.
  • Negotiated critical contracts, partnerships, license agreements, and leases with strategic partners such as Novartis, Chiron, Patheon, Fujifilm/Diosynth, Smith and Nephew, Daiichi/Sankyo.
  • Critical leadership role in multiple US and international regulatory inspections, product approvals, and commercial launches.
  • Developed and executed outsourcing strategy for clinical and commercial supply chain.
  • Hired and developed top performing leaders and teams:
    • Met or exceeded pivotal objectives including product development and commercial launch timelines, commercial and clinical supply, and regulatory compliance for BioMimetic and contract facilities.
    • Led significant enhancements to quality systems and culture of compliance
    • Completed construction and move in on 32,000sf office and laboratory building on time and under budget (~$11M budget).
    • Led design of state of the art aseptic processing facility (fill/finish) (~$20M project budget).
  • Early scope also included financial management and reporting, corporate insurance and risk management, purchasing, and brand development.


Torquin Therapeutics 01/02 - 09/02

VP of Operations

Drug Therapeutics Start Up

Responsible for supply chain, regulatory affairs, and operations.

    • Developed supply chain strategy, regulatory filings, pharma partnership development, and product packaging.
  • Company was unable to secure funding.


JAM Consulting 08/01 - 09/02


Pharmaceutical Operations, GMP Compliance

Consulting service to small pharmaceutical and biologics companies specializing in senior level operations and GMP compliance.

  • Major redesign of quality systems and compliance plan: warning letter lifted.
  • Redesigned flow of operations: increasing labor efficiencies, improving material handling, scrap.


ALK-Abello, Inc. 1998 - 2001

Director of Product Supply

Allergenics Product Manufacturer (Biologic Vaccines)

Executive site responsibility. head of operations, quality, and regulatory for the US operation, HR, supply chain, distribution, and customer service. 

  • Achieved dramatic improvements in delivery performance, cost reductions, regulatory compliance, culture, and strategic planning:
    • Reduced backorders 95%, key cycle time performance 94%, and employee turnover 62%, >$100K in annual cost savings, repeat warning letters cleared.
  • Led major upgrade to Quality Systems and regulatory compliance. 
  • Board of Management team with strategic planning and P&L responsibility.
  • Directed $5M Facility Expansion.


Abbott Laboratories 1983 - 1998

Held a range of positions from entry level R&D technician to mid-level manager over multiple departments. Operations and quality scope in diagnostics, bulk API (drug and biologics), hospital products, and nutritional products. 


EDUCATION: University of California at Irvine

B.S.  Biological Sciences, 1982

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