Scott Donham Email & Phone Number

Seattle, Washington, United States

Schedule phase 1/2 cell therapy manufacturing runs for CPF. Schedule equipment maintenance and calibrations. Develop schedules for new clinical trials. Interact with clinical, research and manufacturing staff to ensure patient treatments go smoothly and assist in rectifying issues when required.

Seattle, Washington

Redmond, Wa

Documentation controlSafety OfficerTraining OfficerQA RepresentativeValidation Specialist

Bothell, Wa

Lead cell culture manufacturing activities from set up; to processing and completion of GMP runs at a 3000L production bioreactor scale in FDA approved facility.Manage between 6-12 cell culture employees, with a range of experience from Manufacturing Technician I through Manufacturing Associate IV.Lead daily, on the floor, production meetings that include task assignment, discuss production and address compliance issues.Performed manufacturing scheduling and planning activities.Manufacturing subject matter expert for SIP/CIP development and validation of new equipment.Participate in ongoing continuous improvement projects using 5S and value stream mapping tools.Participate in deviation response and CAPA teams, employee survey action response team, production planning team, resource planning and new process transfer meetings.Led on the floor activities during start-up following expansion remodel in Bothell, Washington, and shake down run of Berkeley facility in California.Monitor inventory and maintain appropriate levels of items for production and maintenance activities.Reduced equipment build times by creating spinner build kits using lean techniques.Development, use and maintenance of production labor hour spreadsheet.Data analysis of process parameters and labor hours for specialized studies.Experience with root cause analysis and implementation of preventative actions. Equipment troubleshooting and preventative maintenance.

Tigard, Oregon

Responsible for integrating teams of technicians, production designers, engineers and product schedulers in order to improve manufacturing processes in the position of technician to trainer. Performed manufacturing scheduling and planning activities.Developed lean training classes and facilitated training sessions with manufacturing operators. Developed production forecasts for MRP/ERP system. Facilitated 5s and specific citizens for production facility.Developed and implemented process improvement using SMED techniques.Subject matter expert for documentation in FDA regulated environment. Performed testing studies and process engineering functions for new processes. Ensured daily organization, cleanliness, and availability of all lab manufacturing equipment. Developed and installed lean processes into manufacturing areas. Manufacturing representative for new products. Developed SOP’s, MBR’s and validation protocols for FDA approved medical devices. Lead new equipment design team. Participated in onboarding of new equipment for products.

Portsmouth, New Hampshire

Shift lead for cell culture and fermentation manufacturing activities from thaw to 10,000L production bioreactor scale. Set up, processed, and completed GMP perfusion and batch fed runs.Using lean techniques I reduced changeover times by 25% by introducing prepackaged kits, which paired documentation together with replacement parts for preventative maintenance activities.Earned recognition as elastomer change-out specialist by developing procedures to train employees on proper installation during product changeovers.Executed CIP and SIP procedures on all equipment and associated parts used in manufacturing.Developed and revised SOPS for FDA regulated products.Assisted in deviation investigation and CAPA creation.

Greater Seattle Area / Portsmouth, New Hampshire

Tapped to provide manufacturing technical support for $35 million new plant start-up in recognition for exceptional technical skills, manufacturing knowledge and commitment to quality; plant opened on target start date.Implemented best practices and created SOPs for new facility. Oversaw cleaning and testing of new equipment and performed validation work. Guided daily operational activities; including maintenance processes, ordering and inventory of raw materials and supplies, and providing training to production employees.Performed equipment and formula adjustments.Performed troubleshooting of process equipment when production issues arose.Oversaw technical and manufacturing processes to ensure proper functioning of equipment during brewing, filtration, and fermentation activities. Enforced strict quality standards through continuous quality controls and close monitoring of all phases of production processes. Spearheaded development of new products from pilot scale to full production utilizing innovative and experimental brewing techniques.

Auburn / Renton / Everett

Preparation of cost and labor estimates for tools, parts, and other costs for the manufacturing of wing and landing gear sections of the 777. Reduced the time required for cost estimations by developing an innovative cost estimation spreadsheet, which was implemented across other manufacturing groups.Prepared detailed estimates of tools for a variety of aircraft parts.Used standard techniques to formulate data and performed analysis for variances.Created presentations and presented estimation data to high level managers.