---
title: 060
description: A consultant with The FDA Group.
---

[The FDA Group's Consultant Finder ](https://www.thefdagroup.com/find-consultants)

# [060](https://www.thefdagroup.com/find-consultants/60)

 Written by [The FDA Group](https://www.thefdagroup.com/find-consultants/author/the-fda-group) | Sep 22, 2022 6:02:13 PM

**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:
- 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.

- Company was unable to secure funding.

 

***JAM Consulting*** 08/01 - 09/02

**President  **

**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:
- 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

[View full post](https://www.thefdagroup.com/find-consultants/60)

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