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