William James Email and Phone Number

Developed and managed one comprehensive program schedule for Facility renovation, CIP Upgrade and Shut down PMs and Calibration requirements. Facility renovation managed the engineering consultants, equipment vendors, general contractor and coordinated validation and regulatory requirements. CIP upgrade managed URS, supporting document requirements, integration vendor and validation and regulatory requirements. Shut down managed PM and Calibration scheduling and planning. All work completed during aggressive 6 week shut down period, after which operations restarted the manufacturing processes with required validation and regulatory documents in place to restart.

New Product Launch. Developed and managed program schedule for all aspects of new product launch. This included; managing the owners new product launch team, managing facility and equipment engineering consultants and vendors, business process mapping and development, facility staffing and validation requirements, regulatory filing schedule and requirements and etc.

Day to Day Operations of Supply Chain group for Biotest Pharmaceuticals Corp.procurement, Planning, CMO management, all goods receipts, storage and movement for total company operation. S&OP process administration.Work directly for CEO to maintain and improve Supply Chain function.

Manufacturing strategy and project execution for Bio Pharmaceutical client to manufacture preclinical and clinical supplies for oligonucleotide orphan therapeutics. Working directly for Vice Chairman to deliver important business objective. Develop and execute strategy to dispense sensitive raw materials, manufacture, isolate active ingredient, compound and fill parenteral therapeutic.

Process and Automation upgrade for Bio Pharmaceutical client to improve output by 400%. Program management and development of best project approach to deliver project ahead of schedule and within budget. Implemented core team and sub team approach to improve communication and execution by over 300%. Working directly for CEO and Vice Presidents to deliver critical business objective.

$180 MM facility expansion. Design/engineering coordination between 5 contracted Engineering firms and owner. Engineering and construction coordination. Facilitate phased commercial readiness plan between owner and construction & engineering groups.

Director of Operations Advanced Bioprocessing Business Unit Managed brown field design, renovations and operational readiness for industry leading high quality media manufacturing facility for Biopharmaceutical and regenerative therapy industries. This entailed setting the leadership, direction and vision for all teams associated with this venture.  Member of Voice of Customer committee. This entailed meetings with biopharmaceutical industry leaders to understand and detail the current and future needs of this rapidly changing industry. Industry members included Amgen, Biogen Idec, Genentech, Centocor, Wyeth Pharmaceuticals, Human Genome Sciences, Pfizer Inc., Genzyme, Abbott Laboratories, Eli Lilly & Co. and etc. Other responsibilities: Provided overall leadership by communicating vision, strategy and direction to the organization. Defining employee requirements for manufacturing site, develop overall budget prior to finish of construction and qualification execution, developed and implemented strategies for execution of best practices as functional capabilities were launched. Managed an operating budget of $11.3 million. Lead and coordinated VIP visits at the facility.

Guayama Puerto Rico, active pharmaceutical ingredient facility.  Managed an operations budget for Guayama of $7.3 million and rectified 483 observations after site acquired. Set the direction and leadership to respond to and rectify two FDA 483 observations. This entailed developing the strategy and setting the direction by restructuring the 24/7 Operations group to build equipment realibility, quality and continuous improvement into daily operations. The FDA 483 observations were rectified within 6 months with approval inspection by FDA. Decommissioned manufacturing sites and suites with goal of combining at one facility.Miami, Florida final design, construction, qualification and operation of multiuse facility for parenteral and nasal therapeutic manufacturing. Managed the overall design, construction and qualification completion of a $42 million parenteral and nasal multiuse therapeutic manufacturing facility. This entailed understanding and learning the current situation of the delays to the project. Strategy was developed and implemented which entailed restructuring IVAX site functional groups in alignment with final design and construction groups to improve communication and schedule focus to meet milestones. The changes resulted in bringing the project to the PQ and FDA pre-inspection milestone 18 months earlier than existing projected schedule.Miami, Florida Managed various projects for solid dosage facility located in Miami Florida. Projects consisted of: Improvements to packaging lines for employee and product protection. New parts and equipment cleaning area to improve space, flow and drying. Tableting area improvements for material handling and movement. Decommissioned manufacturing sites after IVAX Pharmaceuticals acquired by TEVA Pharmaceuticals.

Primary role was to solidify and grow the Pharmaceutical/Biopharmaceutical Division.  Facilitated the technical capability development of Biopharmaceutical engineering group. This entailed developing training programs for the engineering groups on project scope development, engineering fee estimating, engineering functional analysis, auditing and quality reviews and checks.  Managed various engineering projects from $500 thousand to $500 million in scope.

Facility specializing in pharmaceutical actives and fine chemicals. Implemented changes in external customer focus and operations management to develop a highly efficient customer focused contract manufacturing facility able to respond quickly and efficiently to customer demands. Implemented clear and concise internal customer communication and focus at facility to the total union work group as well as all other functional groups. Led facility in the development of Continuous Improvement systems that improved facility capacity by as much as 300% and reduced waste by as much as 150% for some product lines. Cut safety incidents by over 80% with implementation of best practice behavioral focused safety management system. Managed strategic capital projects from $500 thousand to $50 million in scope. Full ownership of capital project roadmap, scope definition, estimating, ROI, engineering design and installation, qualification and validation, quality & customer service.