Colter Davidson, Pmp Email & Phone Number

Berthoud, CO, US

Durham, North Carolina, US

• Provide single point-of-contact for key partners, ensuring clear and expedited pathway for client executive and process team communications for business/contractual issues and expanding partnership opportunities.
• Part of of 4-member Microbial Network Strategy team, identifying the immediate business decisions impacting the overall network capacity and responsible for clear communication to executive governance regarding the.
• Invited by the Chief Business Officer to lead commercial transformation initiative, working working directly with the CEO and executive team members to stand-up 17 key improvement initiatives and realizing >$130MM of.
• Work with BD, Finance, and Legal teams to negotiate Proposals and Master Service/Commercial Supply Agreements with strategic clients, resulting in multi-year partnerships with portfolio value over $150MM.
• Effectively lead regional program/management team responsible for delivering fully developed early stage programs through late stage and commercial cGMP manufacturing on time, within budget and with high quality results.
• Collaborate with clients, program managers and senior leadership to determine current and future program scope, managing expectations and changes through the S&OP process ensuring adherence to supply plans.

Durham, North Carolina, US

• Manage cross functional teams responsible for delivering defined development and cGMP manufacturing project outputs on time, within budget and with high quality results.
• Plan, organize, monitor and oversee multiple projects to meet defined client requirements, reacting to change proactively to meet client needs.
• Developed and maintain system to onboard newly acquired analytical companies into the KBI systems and processes while identifying and maintaining beneficial aspects of company cultures and skillsets.

Cambridge, Cambridgeshire, GB

• Responsible for leading cross-functional teams in the identification, planning and implementation of innovative process improvements to enable the manufacture of biopharmaceuticals in a higher quality, more rapid and.
• Implemented Lean Production System elements to move the manufacturing organization into an advanced state of Lean maturity in areas of leadership, standardization, visual management, etc.
• Created and managed program utilizing FMEA method to identify and implement changes and new technologies to improve safety, quality, efficiency and/or regulatory compliance through a prioritized evaluation process.
• Managed project with 21 contractors and SME’s to complete CIP Cycle Development and Cleaning Validation, developing tools to remove project from the critical path and complete ahead of schedule for PPQ execution.
• Redesigned finite production schedule interface with Manufacturing, Engineering Operations, Manufacturing Sciences and Technology, Quality Assurance and Quality Control to ensure robust communication and adherence.

Kansas City, MO, US

• Responsible for directing work and coordinating the interface of disciplines and stakeholders, facilitating planning and communication, and driving performance utilizing key financial and schedule metrics (EVA) to meet.
• Prepared capital project proposals for both facility renovation and “greenfield” design projects, including and fee estimates, budgets, and milestone schedules and apply resources to complete projects on schedule.
• Managed and controlled major capital programs across various science and technology companies, providing cost-effective guidance, sound execution, and efficient management from project initiation through closeout.
• Responsible for identifying opportunities for design innovation and project phasing to improve operations, minimize downtime and manage budget throughout design and construction.

Thousand Oaks, CA, US

• Responsible for supervising and coordinating an engineering team responsible for 24/7 Pilot Plant operations during Process Development, Characterization, and Technology Transfer of both mammalian and microbial.
• Led cross-functional teams responsible for coordinating and executing the manufacturing and supply of intermediate and final bulk drug product from cell culture expansion through purification operations.
• Equipped Pilot Plant to support evolving manufacturing technologies through the implementation of single-use systems, alternating tangential flow (ATF) technology, analytics of the future (AoF) and connected processing.
• Implemented Human Performance and Lean Manufacturing tools to improve safety and quality of all operations and increasing plant success rate year over year. Over three years, my team saved over $1.3M and 25,000 FTE.
• Improved strategic planning and management including staff scheduling and forecasting, equipment utilization, and long-range planning across the network.
• Formed a cross-site strategic planning team responsible for long range planning, maximizing staff and equipment utilization. Recipient of Excellence in Operations Award for identifying novel approach to utilize.

Thousand Oaks, CA, US

• Led New Product Introduction (NPI) and facility fit of over 15 new molecules including both microbial and mammalian processes, identifying facility, equipment, and operational gaps and implementing solutions.
• Created several Pilot Plant resource planning and management tools to improve resource and equipment utilization, which have since been implemented across the network and utilized to improve network utilization by >30%.
• Authored and revised Standard Operating Procedures (SOP’s) utilizing checklists and human performance tools to improve safety and ensure aligned operations.
• Led design and commissioning of bioprocess equipment & piping, utilizing bioprocess design expertise. Major projects include design expert on a multi-million dollar bioreactor and chromatography upgrade, consultant for.

Thousand Oaks, CA, US

• Extensive experience in aseptic upstream bioreactor operations including both cell culture and fermentation, with scales ranging from 1L to 15,000L. Authored documentation to ensure aligned unit operations and provided.
• Subject matter expert for harvest (centrifugation, filtration, refold) operations. Assisted in authoring unit operation platform design and documentation and designing/commissioning of harvest suites.
• In-depth knowledge of chromatography and purification unit operations. On several occasions, identifying equipment malfunctions utilizing real-time process monitoring and data analysis. Recommended corrective actions.
• Provided on-floor process monitoring and on-call process support for clinical and commercial operations in several facilities including Thousand Oaks Clinical, Lake Centre Manufacturing, and Longmont Manufacturing.

Thousand Oaks, CA, US

Thousand Oaks, CA, US