Bill Ogden Email & Phone Number

Washington, DC, US

Cambridge, Cambridgeshire, GB

A lead design and project engineer for new capability and large capital improvement projects supporting GMP Clinical Manufacturing.- Lead design and project engineer for a $2MM Hot and Cold WFI upgrade project- Lead manufacturing project engineer for design and construction of a new $50MM, 80K sq ft GMP warehouse.- Supporting manufacturing capacity.

Cambridge, Cambridgeshire, GB

• I managed a group of engineers who support GMP clinical manufacturing. They are the go-to process equipment experts who keep Manufacturing producing.Accomplishments included:
• Lead manufacturing engineer in the design and building of AstraZeneca's first GMP Cell Therapy manufacturing facility.
• Lead manufacturing engineer for a $17MM project to retrofit an existing manufacturing space to a High Containment Suite to perform GMP clinical ADC conjugation.
• Lead manufacturing engineer for a preliminary design and cost estimate to add a clinical scale GMP sterile filling suite in OMW (capable of ADCs as well as standard biologicals)
• Resolved Bioreactor exhaust filter clogging issues
• Led the design, installation and start-up of AZ's first HTST unit for viral inactivation of media used in GMP bio-manufacturing.

Thousand Oaks, CA, US

• Contamination Control Specialist
• Led cross-functional contamination investigation efforts to reduce the risk of microbial contaminations
• Developed and implemented optimization strategies in Cell Culture Manufacturing related to equipment sterilization and aseptic processing.
• These efforts resulted in being contamination free for 2 years, and the elimination of roller bottle contaminations by P. acnes and other organisms
• Participated in the investigation of and recovery from a viral contamination with MMV

• Technical Operations - Project/Process Engineer: Provided technical support to the Bulk Sterile Antibiotic Area including leading annual bulk sterile challenges, conducting Sterility Assurance and Infrastructure.
• Led the initial validation of Media Challenge procedures for the sterile processes in Factory 7
• Led a project to develop a custom, sanitary, sterilizable double mechanical seal to retrofit into a sterile filter dryer to improve sterility assurance and equipment reliability.
• Performed a sterile manufacturing gap analysis of Factory–7 to evaluate sterility assurance and regulatory compliance. This sterile manufacturing compliance report became the basis for evaluating all sterile.
• Revised the CIP and SIP procedures for 14 process vessels.
• Supported various capital projects in the Bulk Sterile Antibiotic Area. Responsibilities included scope, functional requirements, P&ID and specifications development, detailed equipment design, 3D facility and piping.

• Biological Manufacturing Engineering Support:Lead design engineer representing the Biological Manufacturing Engineering Support (BMES), Manufacturing, and Maintenance departments in the design and construction of a new.
• Helped develop and approve all equipment specifications, PFDs, P&IDs, FRS’s, and architectural and equipment layouts
• Participated in 3D detailed skid design, FRS & DDS development, FAT, and IQ/OQ of the Fermentation and Recovery area equipment, the CIP skids, Media/Buffer Prep skids, and the Utility systemsSenior Mechanical.
• Executed capital projects to replace two decontamination autoclaves and two Sharples centrifuges.
• Designed and installed custom mechanical seal for three fermentor agitators and a fermentor mechanical foam breaker. Flow Serve made this seal part of their product line, and it is still available.
• Supported the design and installation of three new clean rooms.

Supervised two utility shops including 14 people. Learned about building and GMP utilities while supporting five Pharmaceutical Production and Sterile Operations buildings. Solved recurring problems with two overloaded HVAC fans, leaking Chilled Water isolation valves, inoperable air handler controls.

Ba, Molecular Biophysics & Biochemistry

Nuclear Power - Engineering

M. Div., Theology / Bible