Expert Details
Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration
ID: 729706
Connecticut, USA
His experience ranges from Venture Capital / new company startups to integration of complex $ multi-billion corporate business and technology acquisitions, clinical and commercial manufacturing and supply with a long list of successful launches of well-known new products across the globe. Adept at developing and leading strategies and business solutions to increase revenues and catapult return on investments he is also an influential change management agent with a hands-on, collaborative style; dedicated to holistic problem solving and continuous improvement. Personable, articulate and persuasive, trusted business advisor and savvy negotiator. He develops Centers of Excellence and high-performing teams and gets outstanding results in virtually any environment or culture. Expert is a strategic thinker and hand-on practitioner that focuses on the accuracy of details without loosing site of the vision.
Expert has extensive experience in improving batch pharmaceutical and biological processes and biotechnology management operations through conflict and change management. He has improved utilization of fixed and variable asset as well as cash management in chemical and batch process plant manufacturing processes, operations as well as plant management. This includes facility management, executive management, cost reduction, risk / crisis management / disaster avoidance, emergency management, environmental and safety management. He has an outstanding track record of regulatory compliance having successfully passed ISO, FDA, EMEA, OSHA and EPA regulatory inspections in several different companies without any adverse findings by the inspection agencies. Expert is computer literate and has experience with a variety of traditional ERP amd MRP systems as well as unique systems for capacity, warehousing and inventory management that have resulted in substantial savings for various companies.
Expert's technology porfolio includes;
Sterile: API, bulk drug product manufacturing, lyophilization, filling and packaging of pharmaceutical, biological, biopharmaceutical injections and ophthalmic products
Non sterile: API, bulk drug product manufacturing, filling and packaging of tablets, capsules, pills, liquids, ointments, creams, suspensions, aerosols, inhalants (solid and liquid) and medical devices
He has experience in consulting for multiple major pharmaceutical and biotech companies in manufacturing and supply chain assessment and implementaion via planning and project management.
Significant and sustainable improvements in cross-functional collaboration, procedures, processes (business and technical) were achieved and resulted in substantial cost savings and customer service.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1984 | Degree: MS | Subject: Interdisiplinary in Engineering, Chemistry, Microbiology | Institution: University of Cincinnati |
| Year: 1979 | Degree: BA | Subject: Biology, Chemistry | Institution: Thomas More College |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2009 to 2010 | Employer: International Partnership for Microbicides | Title: Director Manufacturing (and Supply) Operations | Department: Executive |
Responsibilities:Expert is directly responsible for all internal and external manufacturing and supply chain operations for this company, reporting to the COO. Supported multiple Phase I – III Clinical Trials in the US, Europe and Africa. Direct reports included Process Engineering, Procurement, Manufacturing, Packaging, Materials Management / Supply Chain and Distribution as well as external CMOs and international logistic service providers. (The firm is a non-profit organization that develops vaginal medical devices containing anti-HIV active ingredients to prevent HIV infection in women. The company recently downsized due to lack of donations in the current economy). |
|||
| Years | Employer | Title | Department |
| Years: 2008 to 2009 | Employer: MannKind Corporation | Title: Associate Director, Materials Management | Department: Commercial Manufacturing |
Responsibilities:Expert was Head of Materials Management for MannKind Corporation, reporting to the VP of Manufacturing, provided technical expertise and organizational leadership including; short and long range material requirements planning, warehousing, inventory control, capacity planning, capital and expense budgeting, procurement and materials handling from receipt through final product distribution. Scope included a comprehensive cold chain supply program, product development, chemical, clinical and commercial manufacturing of drug product and medical devices across three sites. (Firm downsized due to additional long term clinical studies required by the FDA for inhaled insulin and device) |
|||
| Years | Employer | Title | Department |
| Years: 1995 to 2007 | Employer: Pfizer, Inc | Title: Director / Team Leader of Global Manufacturing and Supply | Department: Pfizer Global Manufacturing |
Responsibilities:Expert reporting directly to the President of Pfizer Global Manufacturing and served, as a member of the Site Leadership Team for the Division served as internal “consultant” and advisor to senior management and 14 manufacturing sites across the US, Puerto Rico, Canada and Europe on a variety of continuous improvements in manufacturing and supply chain management. Focus areas included; organization development, process, quality and cost improvements, capacity utilization, capital investments, sourcing, materials planning / inventory control and other initiatives.He also served as a primary interface between the R&D and Manufacturing Division as well as 4 sales divisions in global demand and supply (S&OP) planning of clinical and commercial materials. Facilitated multiple project teams driving vital improvements across key performance metrics at major manufacturing sites and distribution centers globally. A core member of the Plant Network Strategy Team for Pfizer Global Manufacturing Expert's primary focus was on new product launch strategies, developing internal and external manufacturing / supply networks, acquisition integration and divestitures. |
|||
| Years | Employer | Title | Department |
| Years: 1992 to 1995 | Employer: Ohmeda Pharmaceuticals | Title: General Manager | Department: Guayama, Puerto Rico Site |
Responsibilities:Expert was the Site Leader, reporting to the VP Operations and directly led two facilities with 13 person management team and 348 total associates in all aspects of plant and supply chain management, engineering, maintenance, materials planning, logistics, quality, environmental/safety, regulatory compliance, HR and finance. Coordinated a $110 Million capital program including pilot plant, construction, approvals and startup of API inhalant anesthetic manufacturing, packaging and warehouse / distribution facilities in Puerto Rico. Obtained FDA and EMEA approval on first inspection (1992-1994)In 1994 Expert was appointed as General Manager of Delta Biotechnology in Nottingham, England. |
|||
| Years | Employer | Title | Department |
| Years: to Present | Employer: Undisclosed | Title: Plant Manager | Department: Baush and Lomb Pharmaceutical Division |
Responsibilities:Available upon request. |
|||
Fields of Expertise
asset management, batch process, biotechnology management, business acquisition, business management, business valuation, change management, chemical plant management, chemical plant operation, clean-room management, clinical management, conflict management, contract service management, cost reduction, crisis management, design management, disaster avoidance, distribution management, document management, emergency management, environmental management, executive management, facility management, factory management, financial management, forecasting, hazardous chemical, human resources policy, international trade, labeling process, maintenance shutdown planning, mergers and acquisitions, startup, technology acquisition, technology evaluation, technology management, technology transfer, turnaround, warehouse management system, co-packer control, pharmaceutical start-up plant, implementation process, cash management, business, merger, homogeneity, improvement, reduction, chemical management, filling process, flow, compatibility, combination, manufacturing profitability, chemical plant manufacturing, management, product, guidance, efficiency, accuracy, instrumentation process, cost, blister pack, time, data, biological process, process, computer software, computer application process