Consulting Agreements United Kingdom

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					                                        STEPHEN M. PONDELL
1418 Meadow Bay Court
Sugar Land, TX 77479                              spondell@umich.edu                                 Phone: 281.253.7088
                                           OPERATIONS EXECUTIVE

 Senior executive specializing in Operations & Supply Chain Management of small-volume, high-value production
   strategies ~ Proven track record starting up new operations, revitalizing stagnant functions, driving quality
  improvements, eliciting cooperation from vendors, management, clients, and employees to improve profits and
          control costs, introducing new products to international markets, and achieving genuine results.

Career Highlights:
    Established a complete supply chain and launched a new pharmaceutical product in Europe, Canada and
       Australia. Product ready to launch in the United States.
    Led a team of over 100, from multiple disciplines, to save a failing product launch and introduce it on time.
    Improved quality performance after moving to a new position and leading a team of 75 through a
       simultaneous organizational change.
Core Competencies include:
  Process Re-engineering ~ Product Development & Commercialization ~ Change Agent ~ Project Management
   Production Plant Management ~ Team Building ~ Strategic Operations ~ Vendor Negotiations & Relations
 Cost Containment/Reduction ~ Labor Force Management ~ Quality Assurance ~ Multi-Site Operations~ Finance
                    MBA, LAKE FOREST GRADUATE SCHOOL OF MANAGEMENT, Lake Forest, IL
                     BSE, Chemical Engineering, UNIVERSITY OF MICHIGAN, Ann Arbor, MI

                                         PROFESSIONAL EXPERIENCE

INTEGRATED BIOTECH SOLUTIONS, Sugar Land, TX                                                             2008 – present
This professional services company provides consulting expertise to pharmaceutical, biologics and device companies in the
development and commercialization of their products, from first-in-man studies to full market entry.
PRINCIPAL

Formed professional consulting company to assist small, emerging companies in the development, regulatory
approval and commercial entry of their products.

    •   Established legal and financial systems for Limited Liability Corporation in Texas.
    •   Developed and implemented brand and marketing strategy, website and corporate capabilities technical
        sheets.
    •   Identified target markets and companies and executed sales calls to cultivate clients and increase market
        awareness of company.
    •   Developed consulting agreements with eight associates to increase breadth and depth of product offerings.

ENCYSIVE PHARMACEUTICALS, Houston, TX                                                                    2004 – 2008
This start-up pharmaceutical company is projecting sales of $100 - $300 million within the next two to three years.
Commercial sales and marketing organizations have been created in the US, Canada and Europe, and manufacturing and
operations are outsourced.
DIRECTOR OF MANUFACTURING

Recruited to establish, operate and maintain the supply chain, including the operations and business aspects, and
ensure product is available at the time of commercial launch. This included setting up and qualifying the supply
chain, selecting vendors, and creating production plans, strategies and tactics. Managed a staff of three.

    •   Evaluated the existing supply chain to determine suitability for commercial production and identify missing
        downstream components of packaging and distribution. Established commercial production system.
STEPHEN M. PONDELL                                  spondell@umich.edu                                   PAGE TWO
ENCYSIVE PHARMACEUTICALS, continued . . . . .

    •   Established pricing and negotiated contracts, reducing costs 10-65% over the previous price structure.
        Bundled some services to achieve maximum leverage and developed contingency plans to safeguard
        against problems at single source suppliers.
    •   Launched a product in several European countries, after putting a supply strategy in place, with product
        being available at the time of introduction for all markets.
    •   Participated in the compilation of the Chemistry, Manufacturing and Controls (CMC) sections of the
        company’s regulatory filings, with responsibility for supporting CMC sections and product labeling
        sections for all filings.
    •   Coordinated validation activities at suppliers, assuring the work was done to appropriate standards of the
        regulatory agencies. Represented company to regulatory agencies (FDA, MHRA, etc) during inspections at
        supplier sites. No product-related observances were noted by any agencies over the course of 4 inspections.

CAMBREX CORPORATION, Charles City, Iowa                                                                  2003 – 2004
Company is a contract manufacturer for Active Pharmaceutical Ingredients (API), with corporate revenues of $400 million.
Products include propriety chemicals, generic API’s and custom contract manufacturing.
VICE PRESIDENT, OPERATIONS / SITE MANAGER

Hired to head the site and oversee all activities, including production, R&D, finance, human resources, plant
engineering and environmental, health, and safety for this 200 person plant. Served as company representative to
the local community.

    •   Maintained excellent safety record during tenure due to continued emphasis on safety to the operating staff
        and complete investigations of all potential safety issues.
    •   Implemented programs to increase employee morale, and initiated a plan to improve customer service,
        working with the extended staff on business processes and actions required to implement the changes.
    •   Identified several growth targets, including the production of controlled drugs, improved process
        technologies, and the manufacturing of potent compounds. This led to the development of a capital and
        business plan to support the strategies.
    •   Led an investigation into a personnel incident regarding the diversion of sensitive company property,
        working closely with corporate legal, and terminated the affected employees. There was no negative impact
        to the business as a result.

ABBOTT LABORATORIES, North Chicago, IL
A multi-faceted health care company, providing pharmaceutical, diagnostic, hospital and nutritional products to a worldwide
market.
DIRECTOR, PLANT QUALITY ASSURANCE                                                                        2000 – 2003

Fast-track promoted to levels of increased responsibility within operations during tenure with the company. As
Director, Plant Quality Assurance, was responsible for the combined Quality Assurance (QA) departments of two
plants, including quality assurance, quality control labs, analytical development, validation and compliance. Headed
an organization of 150 people and reported to the head of divisional quality assurance.

    •   Established appropriate communication channels by conducting team-building efforts to facilitate a
        transition due to a company reorganization. Expanded the goals and activities of the group to align with the
        plant manufacturing areas. Efforts resulted in timely deliveries through active involvement and resolution
        of plant excursions.
    •   Led the local effort to implement key aspects of Quality System Requirements into quality operations of
        the plant. This program was a part of the global corporate response to compliance issues with the
        Diagnostic Division. The successful completion of this activity precluded the FDA from any enforcement
        actions within the pharmaceutical manufacturing division.
STEPHEN M. PONDELL                               spondell@umich.edu                               PAGE THREE
ABBOTT LABORATORIES. continued . . .

    •   Improved compliance and reduced risk inventory levels, lowering compliance exceptions by over 80%, and
        closing 95% of outstanding investigations within 30 days. This successful Corrective & Preventive Action
        program was adopted by other plants in the division. The overall Compliance Program became the
        benchmark within the division.

MANAGER, PILOT PLANT OPERATIONS                                                                   1996 – 2000

Promoted to oversee three local pilot plants and an offsite pilot plant in the United Kingdom. These plants produced
development compounds for the R&D scientists, clinical material supplies for the pharmaceutical division, and
small scale commercial products for internal Abbott use and third party sales. Oversaw the corporate chemical
safety laboratory and the hydrogenation laboratory. There were 100 employees in the pilot plant operations.

    •   Separated the commercial manufacturing operations within the pilot plants from development and clinical
        operations. Installed new equipment, completed process and cleaning validation, and created separate
        commercial and clinical equipment trains.
    •   Assessed potent drug production needs and developed a strategy to address those needs. Developed and
        implemented a multi-year project to improve equipment containment, and a high-potent containment
        module for small scale clinical production. Served as division representative on a corporate task force.

PROGRAM MANAGER, INSTRUMENT SYSTEMS                                                               1984-1986

Recruited to oversee all aspects of a new diagnostics instrument for use in the blood bank market. The instrument
was the first in a series. Oversaw product development including prototyping, software development, marketing,
quality assurance, service, training, manufacturing and reliability engineering. The program staff included over 25
people.
    • In 18 months, led the project from the proof-of-concept phase, through prototyping, to successful market
         launch. Led side-by-side field studies at multiple customer sites in the US and Europe.
    • Successfully transitioned project from development site in Illinois to training, service and manufacturing
         site in Texas.

SECTION MANAGER, TECHNICAL SUPPORT ENGINEERING                                                    1986-1988

Promoted to oversee ongoing support of all marketing instruments in group. Staff was responsible for technical
support to service and customer support areas as well as product improvements for marketed instrument. Oversaw
a group of eight people.
    • Improved reliability of lead instrument by over 50% in first year, through problem analysis, training, and
        manufacturing improvements.

Previous employment: MANAGER, ENGINEERING OPERATIONS; SUPERINTENDENT, CLARITHROMYCIN
MANUFACTURING; MANAGER, ASEPTIC AND LIQUID FORMULATION PLANT ENGINEERING; LIQUID
FORMULATION PRODUCTION SUPERVISOR (ASEPTIC); AND PROJECT & PROCESS ENGINEER FOR ABBOTT
LABORATORIES, North Chicago, IL, and PRODUCT DEVELOPMENT ENGINEER for CHRYSLER
CORPORATION, Highland Park, MI


                           PROFESSIONAL / COMMUNITY AFFILIATIONS

             Former Chairman, University of Houston Biotechnology Industrial Advisory Committee
                     Chapter Secretary, International Society of Pharmaceutical Engineers
                             Board Member, St. Laurence Habitat for Humanity

				
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