Sr Level Engineeing / Operations / Commissioning or Program Management Position.
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
• Master’s 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
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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