Provide leadership of the CMC matrix for an assigned project or portfolio of products. Leading the CMC matrix teams in support of the MPD Leader. Accountable for delivery of all CMC deliverables to the Medicine Development Team/Project Team and the New Product Supply Board. Providing coaching/mentoring of other staff in the CMC matrix to aid effective delivery of their accountabilities and to support their development.• Achieved on-time, on-budget launch of Benlysta into Europe as the Chair of the Benlysta® CMC European Commercial Market Launch Team.• Acquired capitalization, provided strategic goals, and technical leadership and used project management tools to achieve the successful start-up of GSK’s Global Biopharmaceutical Testing and Release laboratory in Stevenage, UK. • Managed the CMC aspects of the Benlysta® commercial supply chain through the first $1 billion sales.• Led a multidisciplinary Team which completed the successful process transfer and scale up with the subsequent regulatory approvals of the Benlysta® DP Manufacturing process into the EU.• Formulated a strategy for improving the International Analytical Technical Transfers using OE tools.• Managed Benlysta post-marketing commitments and clinical trial supply with an annual budget of $8 million.• Achieved the GSK R&D Platinum Level Recognition Award: In recognition of my key role in the approval of Benlysta®.• Negotiated clinical trial resupply of early phase oncology drug of $40 million.

Managed 29-member manufacturing team, mentored, trained and set strategic goals and direction in an FDA approved, multi-shift, 24-hour commercial manufacturing organization responsible for producing Remicade® Drug Substance for Centocor Biotech (currently Janssen Biotech).• Oversaw a successful FDA Pre-Approval Inspection of the Downstream commercial manufacturing stages.• Directed manufacturing activities, and met and/or exceeded all KPI’s associated with batch success rates, product quality, budget, scrap, process deviations, yield, safety and training.• Achieved the GSK President’s Roll of Honor Level, GMS Excellence Recognition Awards (ERA): Innovation & Entrepreneurship for my participation in the Kaizen event to develop a quantitative tool to measure Quality Management Systems (QMS) in-use within the network.• Achieved the GSK GMS Work Area Award ERA: Passion & Urgency in recognition of my efforts to go above and beyond my job responsibilities to assist another production team in preparation for their first successful PAI defense.

NPI Project Manager, 2005-2006Managed a cross functional, multidisciplinary Team in partnership with Centocor Biotech and Jacobs Engineering responsible for delivering the construction, installation and qualification phases for all downstream unit operations enabling cGMP manufacturing capability of Remicade® Drug Substance at GSK.• Managed the on-time, on-cost delivery of the construction and IQ/OQ phases for all downstream operations of the $50 million facilities construction project.• Developed the training protocols for the downstream unit operations and supervised the training of the trainers.• Oversaw the development of all downstream production SOPs and batch records.• Participated in a collaborative pilot program with Emerson to develop a bespoke Process Management Manufacturing Execution System (MES) for the Biotech Industry.

• Supervised and trained a 6-person team of purification production / development personnel in an FDA licensed 3rd party manufacturing facility to produce therapeutic monoclonal antibodies for internal and external clients. Laureate Pharma, Inc., a small (50 employees) contract manufacturing organization, provided development and cGMP manufacturing services.• Managed the design, procurement, installation and qualification of all downstream unit operations during Laureate Pharma’s production capacity expansion project.

• Developed protocols for the purification of dozens of experimental antibodies for internal customers.• Developed in process assays for the monitoring and control of the purification protocols.• Performed cGMP manufacturing for an FDA licensed Diagnostic Monoclonal Antibody.• Initiated product failure investigations and executed corrective/preventive actions.• Managed the development of manufacturing documentation including quality audit responses, deviations, creating/revising SOPs and manufacturing batch records.