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). |
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| 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) |
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| 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. |
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| 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. |
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| Years | Employer | Title | Department |
| Years: to Present | Employer: Undisclosed | Title: Plant Manager | Department: Baush and Lomb Pharmaceutical Division |
Responsibilities:Available upon request. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1981 to 1984 | Country / Region: Mexico / Cualticlan Iscali | Summary: He began his international career as a Plant Manager trainee for Sterling Drug International Group, reporting the the Senior Vice President of International Manufacturing in New York. Expert posted to Mexico as Production Technical Director to implement the first foreign Production Technical Service Department overseeing pharmaceutical liquid, solid dose and sterile manufacturing and packaging processes as well as on site blow and injection molding of bottles, tips,caps. HE also oversaw an offsite CMO manufacturing operations of a broad range of cosmetic products. |
| Years: 1992 to 1995 | Country / Region: Puerto Rico/Guayama, | Summary: 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) |
| Years: 1994 to 1995 | Country / Region: England / Nottingham | Summary: After completing his assigment in Puerto Rico, Expert was appointed as General Manager of Delta Biotechnology in Nottingham, England to assess the processes and begin the process of manufacturing scale-up, facilities and staff required for procduct commercialization. |
| Years: 1995 to 2007 | Country / Region: Pfizer, Inc | Summary: At Pfizer, Expert was initially responsible for technical issues and new products across 7 sites in the US, Canada,Belgium and France. After 2 years his role expanded to 14 sites in the US, Canada, Puerto Rico, Belgium and France. Within another 2 years Expert assumed global supply chain responsiblies across 48 sites. He traveled extensively to Canada, Europe, Puerto Rico and South America. |
Additional Experience
| Training / Seminars |
|---|
| He has trained Directors, Managers and emplyees on cGMP regulations and related policies and procedures relative to all types of Pharmaceutical, Biotech and Medical devices. Expert has also trained and coached Site Leaders and personnel on improving Operational Performance in cost containment / reduction, capacity (asset) utliization, process and capital improvements, inventory management, S&OP process improvement, Right First Time, project management and new product introductions. Expert is also very experienced in developing and formally presenting current situations which effect the Corporation to Senior Management with alternatives and recommended strategies and impact. He has a a track record of gaining senior managment support corporate-wide in execution of these strategies resulting in significant improvment and saving $multi-million. |
| Vendor Selection |
|---|
| Expert's experience includes due diligence, detailed evaluation, contract negotiation and oversight of the performance of selected CMO's in the production of non-sterile and sterile finished products, API, general raw / chemical materials, packaging containers, labeling and cartoning components, manufacturiung and testing equipment suppliers and logistic service providers. He has successfully re-negotiated contracts in dispute with outstanding results. |
| Marketing Experience |
|---|
| Expert is thoroughly knowledgeable in Pharmaceutical and Biotec trends, growth areas, start-up companies, key players, their technologies and cost drivers. He has been tracking new technologies for years and has an excellent understanding of the new wave that is rapidily growing such as; DNA sequencing equipment, stem cells, etc. |
| Other Relevant Experience |
|---|
| Expert's experience includes directly living in and managing flagshop operations in various countries; Mexico, Puerto Rico, England, and of course, the US. In addition, he has had extensive global manufacturing and supply responsibility across Canada, South America, Europe, Africa, Australia and Asia. He speaks Spanish and a little German. |
Language Skills
| Language | Proficiency |
|---|---|
| Spanish | He is proficient in speaking, reading and writing in Spanish with a near-native Spanish accent but a little rusty for lack of the need to use it. |
| German | He has a basic understanding of some German but has not used it for several years. |
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