Project management professional with broad bioprocess and facility engineering, project management and leadership experience within the biopharmaceutical manufacturing field at early-stage clinical through commercial scales. Excellent track record in the management of functional areas, capital projects and CMO programs to consistently meet technical, supply, financial and compliance targets. Ability to baseline new or underperforming projects, programs and relationships and establish structure and control to find win-win solutions and long-term success for all parties involved.

 Managed major client CMO program with ~$47MM in annual revenue generation, tracking milestones and deliverables against quality, schedule & cost targets and resulting in successful transition from PIII through PAI and commercial launch campaign  Primary point of contact between multiple client functions and GSK functional areas to establish effective communication paths, transparency within teams and well-managed expectations from internal & client customers  Efforts resulted in high level of client/internal satisfaction regarding performance of CMO projects to plan and cohesiveness of client/GSK project teams  Strong focus on scope control and impact to resources and quality through change control and work plan/contractual development  Capital projects routinely executed according to schedule/budget while meeting quality and deliverable reqs.; equipment/facility turnover to end user managed through operational readiness stage Demonstrated ability in effectively adapting to evolving scenarios and personnel issues  Led successful investigations for contaminations, elevated bioburden and equipment failure  Co-chair for new equipment reliability program; expanded program by targeting standardized data entry and analysis, value-added improvements and program visibility  Served as first facilitator of site Senior Leadership Team (SLT) and Extended Leadership Team (ELT) As SLT facilitator, developed meeting strategies and tools to ensure effective meeting time driven towards full engagement and decision-making As ELT facilitator, created team charter to focus team of managers and people leaders to effectively define and solve site issues related to personnel, resource mgmt., etc.  Led interactions and marketing efforts with prospective clients in an effort to maximize GSK capacity utilization Chaired teams to develop RFI, RFP, etc. to successfully demonstrate GSK CMO capabilities Planned and hosted client due diligence visits

Providing upstream, downstream and bulk fill support to the manufacturing groups at the Small Scale Manufacturing (SSM) facility. Member of the Investigation Team charged with performing root cause and CAPA analysis for failures and incidents.

Played lead role in start up of fermentation, lab supprt and fill/finish cGMP manufacturing facilities. Acted as the manufacturing supervisor for each of these activities during start up and continued use. Developed training program for manufacturing group and acted as the training manager.

Day to day activities included batch, sterilize, sample and harvest bench scale fermentors. Large scale fermentation work included batch, SIP, CIP and harvest through disk stack centrifuges. Building on previous fermentation experience, developed batch records for process development fermentation processes. Assisted in tech transfer of PD fermentations to cGMP manufacturing.

As a student at the University of Maryland, I worked as a lab technician in this process development pilot laboratory. Performing various fermentation and purification processes for clients, I learned and operated bench scale through 250L fermentations, as while as use of AKTA Explorer and Pilot use for purification. My typically 25-30 hour work week included fermentor batch, SIP, sampling, harvest and maintenance. Also included development procedures for new AKTA skids and development of learning materials for professional education programs and university classes.