Oversee the execution of large scale capital projects, including construction of cGMP manufacturing facilities and labs. Lead cross functional teams to foster a collaborative and inclusive culture that creates innovation and creativity. Focus on developing long-term plans that align with company goals and objectives.

Deliver Cell Therapy patient customized medicine. Oversee and provide direction for multiple site capital projects to assure that they are safely completed on-schedule, within budget, and in accordance with governance protocols. Plan and define project goals and devise methods to accomplish them. Endorse contract terms and company policies. Set tactical guidelines for project management and execution of projects. Monitor assigned projects within the portfolio and ensure that project objectives are being met. Provide a high degree of creativity, foresight, and mature judgment in directing extensive programs of significant importance.

Delivered technology platforms to deliver drug substance product. Drive management of financial and portfolio goals to achieve budget targets. Direct and manage numerous multimillion-dollar projects in portfolio totaling ~$500M/yr. Communicate priorities, identify and resolve issues, and escalate to appropriate governance structure. Responsible for operational safety and promoting a safe work environment. Develop strategic direction for project activities to formalize scope, schedule, and budget estimates so that project execution planning and forecasting may be completed. Implement cost effective solutions throughout the course of a project, while maintaining business objectives and milestones. Apply knowledge of engineering principles to broad variety of assignments in related fields. Develop and implement technical solutions to complex problems requiring the regular use of ingenuity and creativity.

Delivered Tech Transfer program to establish Amgen, Thousand Oaks, as primary supplier for drug substance product. Direct and manage project in accordance with the project management methodologies. Develop and maintain the project budget. Responsible for developing cost effective solutions throughout the course of a project, while maintaining business objectives and milestones. Direct interface with representatives during regulatory inspections and audits (FDA, EMEA, etc.). Maintain, interpret and review utility, process system/equipment P&ID’s. Direct team for start-up, commissioning, testing, validation, and engineering verifications. Employ engineering techniques and/or modifications of advanced techniques within area of engineering expertise. Apply engineering principles to broad variety of assignments in related fields. Partner with departments to develop requirements and recommendations for large and/or highly complex system/facility modifications.

Delivered facility at Amgen, Thousand Oaks, which is qualified for use to manufacture early phase clinical current Good Manufacturing Practice (cGMP) Active Pharmaceutical Ingredients (API) product. Equipment included Kilo Operations with an additional Kilo Reactor, Hydrogenation Reactor, Chromatography Purification, Filter Dryer, Double Cone Dryer, Radiosynthesis Suite, and support functions (material storage, weigh/dispense, milling). Assist in the development of Maintenance Vision, Mission, Strategies, and Goals that provides guidance to becoming the best maintenance organization. Direct/plan/delegate tasks to personnel regarding daily operations, corrective action, and preventative maintenance activities in a reliable and compliant manner. This includes, but is not limited to, maintenance and emergency repair of all production related process and facility equipment, HVAC, and utilities systems. Typical equipment would include but is not limited to autoclaves, HEPA filters, high purity water systems, sanitary distribution systems, steam, chilled water, chilled glycol, process gases, electrical distribution systems, EMS/BMS control systems, and process control systems. Provide technical, project, emergency response, trouble shooting, and preventative maintenance support for facilities and related equipment. Maintain, interpret and review utility, process system/equipment P&ID’s. Responsible subject matter expert during compliance inspections. Provide solutions to a variety of technical problems. Manage, schedule, and process all related cGMP documentation associated with maintenance operations. Evaluate current maintenance procedures and make appropriate changes to optimize the maintenance program. Ensure all corporate change control procedures are followed and maintained.

Successfully engineered Clinical and Commercial drug substance systems to deliver human therapeutics. Provide solutions to a variety of highly complex technical problems of large scope. Provide engineering expertise for the design, procurement, installation and start-up of utility/facility systems including Purified Water, WFI, Clean Steam, HVAC and plant utilities. Provide engineering services with troubleshooting and technical support for the utility and facility operations. Function as a technical expert to equipment or systems regarding troubleshooting and operations. Lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments in developing requirements and recommendations for system modifications. Responsible for completing Root Cause Analysis work orders for equipment/system failures and implementation of preventative actions based on findings. Maintain operational understanding of equipment/systems and ensure operational procedures are up-to-date. Define the Preventative Maintenance, instrument process tolerances, and calibration frequencies for manufacturing utility, facility, and equipment/systems to ensure they operate reliably and per specification. Responsible for responding to HEPA Certification Alerts, Calibration alerts, sanitary utility alerts/action investigations, and equipment/system/facility incidents. Responsible for the review and execution of validation activities for new, existing, or upgraded equipment/systems.