Responsible for all Operations, Product, Business and Strategic Development as well as the Quality and Commercial Operations within the Nostrum Laboratories business unit.

Consulting in Compliance, Dosage Form Design, Product and Process Development as well as Technology Transfer. Consulting in Pharmaceutical Operations.

Responsible for the leadership and growth of the US product development organization, both internal and external projects including Formulation Development, Analytical Development, Drug Metabolism/Biopharmaceutics, Medical Affairs, Process Development and Project Management. Led US operational functions including Technical Services/Technology Transfer. Responsibilities included multi-site workforce of up to 160 people and M$70 expense budget and M$5 capital budget.Responsible for US… Show more Responsible for the leadership and growth of the US product development organization, both internal and external projects including Formulation Development, Analytical Development, Drug Metabolism/Biopharmaceutics, Medical Affairs, Process Development and Project Management. Led US operational functions including Technical Services/Technology Transfer. Responsibilities included multi-site workforce of up to 160 people and M$70 expense budget and M$5 capital budget.Responsible for US development of all dosage forms including solid (IR and MR), dermatological, respiratory, liquids and other.Significant AccomplishmentsRe-invention / Organizational redesign of US Development Center.As Executive Sponsor of project, oversaw design and construction and start-up of new 30,000 square foot generic R&D center in East Hanover.Raised quality and quantitative levels of ANDA submissions significantly through increased levels of commitment, improved team work and much improved project focus and ownership Show less

Overall responsibility included internal and external research and development functions for both generic and branded products. Organization included Formulation Development, Analytical R&D, Drug Metabolism/Pharmacokinetics, Process Development, Project Management, Documentation and Regulatory Affairs. Responsibilities included a multi-site combined workforce of approximately 110-120 people with an expense budget of approximately $60M and a capital budget of $3M.Significant… Show more Overall responsibility included internal and external research and development functions for both generic and branded products. Organization included Formulation Development, Analytical R&D, Drug Metabolism/Pharmacokinetics, Process Development, Project Management, Documentation and Regulatory Affairs. Responsibilities included a multi-site combined workforce of approximately 110-120 people with an expense budget of approximately $60M and a capital budget of $3M.Significant AccomplishmentsSignificant increase in ANDA submissions as well as significant increase in ‘first to file’ (FTF) submissions through increased levels of teamwork, much improved project focus and instilling of strong levels of commitment and project ownership to project completion. Show less

Overall responsibility for the leadership and growth of the US PD organization included Formulation Dev, Analytical Dev, Drug Metabolism/ Biopharmaceutics, Process Dev, Project Management and Reg Affairs as well as Tech Services/Tech Transfer and Validation, Globally managed all multi-national generic development programs, including the management of international sub-groups such as Regulatory Affairs, Bioequivalence and IP Coordination. Served as General Manager, IVAX India, with full… Show more Overall responsibility for the leadership and growth of the US PD organization included Formulation Dev, Analytical Dev, Drug Metabolism/ Biopharmaceutics, Process Dev, Project Management and Reg Affairs as well as Tech Services/Tech Transfer and Validation, Globally managed all multi-national generic development programs, including the management of international sub-groups such as Regulatory Affairs, Bioequivalence and IP Coordination. Served as General Manager, IVAX India, with full operational and fiscal responsibility and project responsibility, including a 50 person Dev Center in Mumbai. Multi-site US based organization included a combined workforce 120 US based personnel with an expense budget in excess of M$8.0 annually.Significant AccomplishmentsOrganize and chair Global Generic Development Steering Committee – Globally manage all multi-national development including organize and manage global sub group functions in Regulatory Affairs,IP coordination and Bioequivalence management.Direct and manage IVAX-India and India based development operation Organized Tech. Ops. function, focused on global standardization of development operations practices in validation, technology transfer, documentation and process optimization.Created Project Management function focused to ensure all projects on schedule and proactively identify and overcome obstacles.Elevated Technical/Scientific expertise across the Dev. organization.Improved efficiency and focus of the PD group resulting in an increase from six (6) ANDA submissions in 1997 to eighteen (18) ANDA submissions in 1998.From 1998 through 2003 submitted an average of eighteen [18] ANDAs per year.Established ten (10) year plan as part of planning process for PD, representing the first time this plan existed within the IVAX organization.Directed NJ/ NY multi-site manufacturing operation which, at its peak operation resulted in manufacture, packaging and distribution of over B1.0 units. Show less

Senior Director, Pharmaceutical Development/Technical Services Worldwide (1995 to 1997)Directly supervised all phases of Formulation Development and Process Development including all dosage forms as well as Formulation development of Biotechnology products. Also included Technical Services responsibilities for all Ortho-McNeil manufacturing facilities and coordination of Cilag Formulation / Process Development Development activities globally.Senior Director, Pharmaceutical Process… Show more Senior Director, Pharmaceutical Development/Technical Services Worldwide (1995 to 1997)Directly supervised all phases of Formulation Development and Process Development including all dosage forms as well as Formulation development of Biotechnology products. Also included Technical Services responsibilities for all Ortho-McNeil manufacturing facilities and coordination of Cilag Formulation / Process Development Development activities globally.Senior Director, Pharmaceutical Process Development/Technical Services Worldwide (1992 to 1995)Managed all Process Development and Technical Service responsibilities, including scale-up, plant introduction/technology transfer, validation, and ongoing process troubleshooting and optimization. This included the leadership of the Pre-Approval Inspection preparation program. These responsibilities were spread over three (3) development facilities and five (5) manufacturing facilities, in the U.S., Puerto Rico and Switzerland.Director, Pharmaceutical Process Development/Technical Services (1989 to 1992)Led all Process Development/Technical Service responsibilities of Ortho Pharmaceutical Corporation products and facilities.Significant AccomplishmentsFounded and chaired the Pharmaceutical Technology Core Group, and international team, representing all J&J pharmaceutical R&D groups. All parties met to share information on new technologies being investigated and new licensing opportunities to review, from a technology perspective.Organized the Pre-Approval Inspection preparation program. This program systematically prepared the organizations involved for specific pre-approval inspections at scientific sites. The program became known throughout the pharmaceutical industry as among the best, with a proven track record of no approval denials during the program’s management. Show less