Site supply chain planner supporting the filling process of three Varicella vaccine drug products for the domestic, EU and/or ROW markets. Created the production plan and adjusted when needed to ensure sufficient supply of filled product for packaging sites.-Monitored production, testing and release activities to ensure shipments arrived to the customer on-time and prevent build-up of inventory. Escalated when issues arose that risked supply and worked with stakeholders to accelerate timelines to overcome gaps. -Supported initiatives that increased production capacity. Provided planning input and support to assist in implementation of project that enabled a 24% increase of capacity for one product. Identified and implemented changes that increased capacity of the other two products by 21% and 18% by modifying batch size and run rate.-Secured sufficient materials to maintain production yet remain within financial targets.

One year assignment supporting the Durham Quality Laboratory. Aligned laboratory testing with production and release schedules. Set testing priorities and provided guidance when issues arose. Batch testing on time increased to approximately 83.3% in 2017 as compared to 55.5% in 2016.-Developed testing dashboard to monitor progress on a batch-by-batch basis. Used dashboard to highlight risks and timelines necessary for success.-Mapped out testing, developed capacity model, compared capacity versus production, identified any gaps and provided recommendations to help resolve issues.

Led long-term and short-term detailed scheduling activities. Adjusted the schedule as needed to maintain the production rate and to create opportunities for non-routine equipment maintenance, repair of facilities, training and for engineering runs of an expansion. Administered and maintained the Orchestrate scheduling system.-Created capacity models based on equipment utilization, FTE requirements and process bottlenecks. Created operational models that compared efficiencies and headcount required for production at two separate facilities. Identified opportunities to overcome headcount bottlenecks via cross-training. Developed scenarios and presented recommendations for increasing and decreasing production rate.-Managed 2014/2015/2016 shutdowns. Determined scope of shutdown for facility and evaluated projects. Ensured adherence to shutdown schedule and successful restart of production.-Member of 2014 VBF Lead Time Reduction project. Developed tool used to ensure make/test/release activities remained on-track. Hired contractor to maintain information used in the tool. From 2014 to 2015, lead time of make-to-release of clarified bulk decreased from approx. 170 days to approx. 110 days.-Managed Hoshin Kanri project portfolio for the IPT

Responsible for implementing a risk management program for product development of Pfizer’s biologic portfolio, spanning Phase II trials to commercial launch. This program increases efficiency of developing and transferring processes by identifying technical gaps. The output of this program also acts as a foundation for continuous improvement post commercialization.Scope of work included training teams on the methodology, supervising the collection of information in each program and leading risk assessment sessions. Teams were comprised of research, regulatory, quality, technology and manufacturing organizations.Projects included vaccines, recombinant proteins, monoclonal antibodies, antibody-drug conjugates and biosimilars.

Process optimization and technology transfer of commercial processes.Laboratory experience includes designing and executing studies supporting scale-up / scale-down, process improvement, product comparability, qualification of alternate suppliers of raw materials and equipment, cross-licensing and root cause investigation. Experience during technology transfer campaigns include advising and leading cross-functional teams, authoring engineering and study protocols/reports, managing testing with internal/external laboratories and process modeling using computational fluid dynamics. Provided hands-on support domestically and overseas.Additional experience includes equipment validation and initiating/managing process change requests. Also supported the development of a network capacity model by evaluating baseline assumptions on cycle time, resources, yield and bottlenecks.