Seasoned executive motivated by technical and organization challenges with a strong record of achieving successful results through the seamless implementation of key corporate programs / initiatives that aid profitability, productivity and quality. Recognized for vigorously managing multifaceted pharmaceutical FDA accreditation projects, applying stringent standards and rallying cross-functional / multi-company team participation.
Verifiable track record in directing Operations and Validation through dynamic leadership, strategic planning, and in building effective organization teams. Experience spans from starts-ups to mature companies. Professional strengths include:
Building Strategic Relationship & Change Agent
Developing & Retaining Professional Talent
Multi-Company Alliance Team Leadership
Technical Transfer & Contract Site Implementation
Multi-Site Facility Operations
Masters Manufacturing Engineering, Northwestern University.
Program Design, Development & Management
Process Improvement & Lean Manufacturing
Accreditation Audits & Documentation Review
Capital, Contract Manufacturing & Development Project Oversight
Commissioning Program Development & Management
US CITIZEN
BUSINESS EXPERIENCE
(Major Pharmaceutical Manufacturer, Commercial sales > $ 900M)
Director of Projects (2006 Present)
Spearheaded Contract Engineering and Contract Manufacturing programs, accomplishments include:
Led the technical transfer of processes. Developed technical transfer plans, site integration plans and tracked progress.
Co-managed a new contract manufacturing site start-up for product device assembly. Site will support the forecasted marketing supply of a commercial product. Oversaw project schedule, supported start-up and process validation runs.
Established the corporate standards for engineering and project management functions.
Managed the program team that produced dramatic world class award winning results including:
Pioneered a strong partnership resulting in meeting stated Project goals of schedule and budget.
Scope of project included full campus build-out including filling suite and bulk manufacturing area.
Administered all aspects of the project development including design, contract bidding / negotiations, budgeting and scheduling. Oversaw the start-up, commissioning testing efforts and presented the project updates to the senior management and multi-company Alliance teams
(Biotech Start-up, Melanoma Whole Cell Technology)
Director of Pharmaceutical Technology (2004 2006)
Responsible for the Engineering Operations including facility & site engineering support. Accomplishments Included:
Selected by Executive Management to lead a multi-million capital expansion project that developed a manufacturing site for a cutting edge biotech pharmaceutical product.
Reorganized facilities department and created Site Operations Dept. Minimized downtimes to < 5% and consistently met approved budgets. Managed the process equipment development studies.
(Pharmaceutical Manufacturer, Commercial, Sales > $ 1 Billion) -
Associate Director of Validation (Commissioning) & Metrology (1998 2004)
Responsible for the Validation & Metrology activities for the site. Accomplishments included:
Directed the validation testing to support the licensure of FMC Site for biotech product. This included all of the equipment, facility utilities, cleaning, automation and others. Over 135 documents were developed and executed.
Documents included specifications, user requirement, functional requirement, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), impact assessments and validation summary reports with a focus on cGMP impact and validation lifecycle requirements including change control and revalidation / requalification plans.
Revamped the metrology function ensuring that all calibrations were compliant with SOP. Enhanced existing Metrology Policy and Operating Procedures.
Key Member of the team that supported regulatory inspections. Interfaced with inspectors resulting in minimal citations. Interfaced with FDA PAI team and supported team bio-inspections.
Developed and implemented Corporate Quality System to multiple operational sites.
(Pharmaceutical Manufacturer, Clinical Site, Sales > $ 1 Billion)
Associate Director of Engineering & Validation (1994 1998)
Responsible for Site Operations, Engineering and Facilities which included directing activities of approx. 20 staff members. Accomplishments included:
Spearheaded site start-up, facility and equipment upgrades and validation testing
(1991-1994) - Sr. Project Engineer (1991 - 1994)
(1987 1991) Engineering Manager & Project Manager
(1985 1987) Contract Engineer
EDUCATION & AFFILIATIONS
Northwestern University, Evanston, IL. Master of Manufacturing Engineering, 1987
University of Oklahoma, Norman, OK, Bachelor of Science in Industrial Engineering, 1984
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