A. Schering-Plough (6/00-present)

Vice President, Global Quality Services (10/2006-present)
Responsible for providing analytical/troubleshooting support to all S-P manufacturing sites and, consistent, compliant and efficient global business processes to sites. Responsible for the management of the global customer complaint management system, documentation system, stability and change control system.

• Member, Global Quality and Supply Chain Leadership Team and Corporate Quality Council
• Member, Global Primary Care Development Council
• Member, PAT Governance Committee
• Member, Global Leadership Development Task Force
• Member, Specifications Development Council
• Member, SP Women’s Network
  

Vice President, US Quality Operations (7/2002-9/2006)
Led the development and implementation of the US Quality Strategy for four manufacturing facilities. Managed a staff of over 600 colleagues with an internal budget of $60MM

• Developed policies, systems, processes and practices  which ensure products are manufactured, packaged and marketed in accordance with current FDA and SP standards for Quality, Efficacy, Safety, Potency, and Purity. 
• Provided strategic guidance to the consent decree sites, ensured all relevant commitments in the Consent Decree for the New Jersey facilities were met in full and on time. Built a culture of sustainable compliance and executional excellence.
• Established relationships between district FDA offices and SP Quality and Supply Chain management.
• Established governance councils for compliance and business priorities
  

Senior Director, NJ QC Operations (2001-2002)

• As Site Quality Head for New Jersey commercial operations, evaluated all products for compliance and recommended viability of the product line.
• Directed the implementation of Trackwise tracking system for Customer complaints and Investigations. Implemented the Site Quality Council
• Established regulatory inspection management program and tracking system for commitments.
• Developed a cross functional forum for product status and tracking.
• Implemented site Business Council
  

Director, QC Testing (2000-2001)

• Established measurements and metrics for all laboratory operations related to the analytical and microbiological testing of raw materials, drug substances and finished products in support of production operations.
• Established a culture of excellence and continuous improvement.
  

B.  Hoffmann-La Roche (1991-2000)

Director, Pharma Manufacturing-Sterile and Liquid Production (9/96-6/2000)
Responsible for directing, controlling and coordinating activities associated with the production of Sterile and Liquid pharmaceuticals. Overall responsibility for product quality, operating efficiency, employee safety and customer service necessary to meet divisional revenue and profit objectives.

• Reduced cost of goods by bringing in volume as a contract manufacturer
• Managed the manufacturing arrangement and interactions with Bayer for Femstat
• Led the Sterile Operations Re-qualification Plan
  

Director, Quality Control-Microbiology (7/1995-9/1996)
Responsible for directing all activities related to microbiological and environmental monitoring  support  to the Nutley and Totowa Sterile Production sites, Chemical Operations, biopharmaceutical Manufacturing and Pharmaceutical R & D.

• Successfully managed a significant microbiological issue for a product launch
• Directed the implementation of product testing isolators
  

Associate Director, Quality Control-Chemistry (2/1994-6/1995)
Directed the activities of scientists responsible for analytical testing of raw materials, drug substances, finished products and clinical materials.  Overall responsibility for the marketed stability program, customer complaint program and technical support for commercial production.  Directly responsible for monitoring and ensuring the quality of products marketed by Roche Labs, Inc.

• Implemented a significant reduction in re-testing frequency
  

Associate Research Investigator (7/1992-1/94)
Manage activities of the group providing special analytical/troubleshooting support and characterization  for marketed products.

• Led the investigation for Provocholine degradant
• Established Analytical transfer and method transfer policies
  

Senior Scientist (1/1991-6/92)
Develop, validate and improve methods for marketed and research products.

C.  Lederle Laboratories

Analytical Development Chemist (Team Leader) – (11/1988-1/1991)
Method development, validation and analytical troubleshooting for marketed products.

D.  US Environmental Protection Agency

Post-Doctoral Scientist (Summer 1988)

Responsibility:
Method development and validation for analysis of PCBs, VOCs and pesticides in water, sediments, soil and ambient air.

Education

Masters in Business Administration (minor in Marketing) - Rutgers University (1999)
PhD in Physical Chemistry - University of California, San Diego (1988)

Professional Affiliations

ACS, PhRMA, PDA, AAPS, ISPE

• AAPS-APQ Planning Committee Member 1996 & 1997
• PhRMA Dissolution Subcommittee Member 1994 & 1995
• PDA Regulatory and Chemistry Affairs Committee 1997
• PDA Planning Committee 1996, 1997, & 1999
• Schering Plough Co-Chair AHA “Go Red For Women” 2006
• AHA Go Red for Women Fund Raising Committee, 2003, 2004, 2005, 2006
• Newark Beth Israel Medical Center Foundation, Auxillary Committee
• Wharton Business School, Judge for 2007 Wharton Business Plan Competition
  

Awards and Presentations

2002 – TWIN Award
2002 – Schering-Plough Management Excellence Award
2006 – Schering-Plough Distinguished Contributor Award

The Open Partnership
Email: Open.Partnership@njit.edu
Phone: 973.642.4671
www.njit.edu/academics/provost/openpartnership