Vice President, Quality Operations, Therapeutics Manufacturing and Development (TMD), Genzyme Corporation

• Responsible for all quality operations supporting therapeutic protein and peptide programs. TMD Quality encompasses Quality Assurance, Quality Control, Validations, Stability/Statistics, Quality Systems, Quality Control Technical Services, and Product Data Management Systems.
  • Quality Operations is composed of approximately 170 technical persons with an annual operational budget in excess of $10 million and capital budget in excess of $1 million.
  • Six direct reports are professional individuals ranging from Senior Manager to Senior Directors.
• Direct all facets of the quality operations for Therapeutic Protein and Related Products
  
• Review and sign-off of relevant sections of submissions to regulatory agencies worldwide
  
• Analysis and resolution of designated regulatory agency questions concerning product complaints, regulatory submissions, and data analyses, and testing issues
  
• Responsible Quality Assurance representative for regulatory inspections and certain regulatory communications
  
• Genzyme representative for assessment of quality issues and systems of partner companies, potential partner companies or acquisition candidates
  
• Direct certain quality operations (Stability/Statistics) which support other manufacturing divisions (Biosurgery, Pharmaceuticals)
  
• Integrated all aspects of quality supporting therapeutic protein manufacture, testing and release to a single focused team
  
• Directed the assessment of quality practices at two manufacturing sites and instituted a program of best practices across all sites
  
• Directed the assessment of quality practices at two manufacturing sites and instituted a program of best practices across all sites
  
• Served as a member of due diligence team investigating and facilitating the acquisition of a licensed publicly held company
  
• Directed the integration of the quality systems of the acquired company into TMD Quality Organization
• Directed the implementation of a system of performance metrics for the Quality Organization
  
• Served as Genzyme responsible person for multiple regulatory inspections (CBER, CDER, HPFB, GCC) at two manufacturing sites

Vice President for Quality Control, Genzyme Corporation (Jan. 1996 - Feb. 2002), Director Quality Control, Genzyme Corporation (Apr. 1992 - Jan. 1996).

• Directly responsible for operations of six quality control laboratories, with a staff of 86 and multi-million dollar budget, which conducted:
  • Testing and release of raw materials, including a centralized testing facility supporting multiple manufacturing sites
    
  • In-process, product release, and stability testing of multiple therapeutic protein and device products
    
  • Microbiological monitoring of personnel and facilities supporting aseptic filling and lyophilization processes
    
  • Microbiological monitoring of facilities supporting mammalian cell culture, bacterial fermentation, purification processes, and product formulation
    
  • In-process, product release, and stability testing of multiple therapeutic protein products in clinical development and evaluation
    
  • Assay development, modification, optimization, validation and transfer from and to other laboratories
    
  • Participation as member on product development teams for the design of therapeutic and device products, defining quality and stability indicating parameters, establishment of suitable test protocols, and compliance with cGMPs and ISO standards
    
  • Writing and review of sections of IND, IDE, NDA, ANDA, BLA, MAA, and PMA submissions to regulatory agencies in several countries including the US, EU, Canada, Australia/New Zealand, Japan, Israel, etc.
    
  • Analysis of and resolution of certain regulatory agency questions concerning product complaints, regulatory submissions, and data analyses, and testing issues
    
  • Serving company as a senior member of team representing the company during regulatory/compliance inspections by US FDA (CBER, CDER, CDRH), UK MCA, Canada HPB, other pharmaceutical companies, and country agencies
    
  • Providing technical assistance as needed to other company groups including quality assurance, regulatory affairs, corporate compliance, technical development, validation and medical affairs
    
  • Serving as corporate QC liaison to other company divisions, partner companies, and QC operations in Japan, UK, and Switzerland
    
  • Representing company in discussions and negotiations with regulatory agencies and partner companies on matters relating to testing and release of therapeutic products
• Directed, monitored and defended the growth of the Quality Control organization from approximately twenty five individuals at two locations to the current 85+ person operation with six laboratories at three US sites. These QC operations have been successfully reviewed for ISO certification, multiple product pre-approval inspections and annual inspections by client companies, FDA (CDER, CDRH), MCA, Slovenia, Canada, and other country representatives.
  
• Defined and defended company policies for data manipulation and out of specification (OOS) situations
  
• Led in the design and qualification of four new Quality Control laboratories comprising in excess of 25,000 ft2
  
• Proposed, justified and established a new Quality Control operation (QCTS) devoted to non-routine laboratory operations. This group brings considerable credibility to the quality operation and facilitates the transfer of new technologies to the quality organization.
  
• Directed the transfer of product release test methods to three QC laboratories in three countries. Those QC laboratories, personnel, and test methods successfully met local government inspections.
  
• Identified the need for a central LIMS covering all QC operations, identified and hired senior level LIMS management. This LIMS successfully met the Y2K challenge.
  
• Directed a review of all environmental and utility monitoring programs across all sites. This review led to a rationalization of monitoring practices to meet universal standards and led to consistent practices across all manufacturing sites.
  
• Participated in and contributed directly to, the validation planning process for the commissioning of a new biotech manufacturing facility
  

Manager, Quality Control Operations, Biogen, Inc.

Manager, Quality Control and Analytical Chemistry, Biogen, Inc.

Manager, Quality Control Chemistry, Cutter Biologicals (Currently Bayer Corp.)

Academic appointments as Assistant Professor of Chemistry and Sciences at Brescia College (KY), University of Pittsburgh (Bradford Campus), and Columbus College (GA)

PROFESSIONAL SOCIETIES
American Chemical Society
PDA