John Purdon Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Customer liaison for all construction projects on site. Responsible for Quality plan development and execution, system testing and turn over package documentation delivery to client. Provide GMP/Life Science training to both internal and external audiences.

United States-East Coast

Providing pollination services to East coast growers.

Selma, Nc

Providing engineering, project management and documentation services, primarily to the pharmaceutical industry.

Wilson, Nc

Managing commissioning, qualification and validation of utilities and facilities for the Fresenius Kabi IV solution expansion project.

Asheville, North Carolina Area

Responsible for overall management of multiple FDA remediation work streams to eliminate compliance issues, including manufacturing processes, GMP Systems, Critical Systems, Facilities and documentation control.Direct the activities of multiple project managers, schedulers and client plant personnel to define project scope, technical design, capital investment requirements, execution, qualification and documentation required for each work stream.

Wilson, North Carolina

Manage leadership teams to assure execution of all site manufacturing and packaging activites in support of compliance, financial and customer service goals.Interface with site support groups (Quality Assurance, Technical Services/Validation, Engineering/Maintenance, Supply Chain) to assure alignment with Operations requirements.Participate in development and execution of strategic site initiatives (Quality compliance/FDA readiness, site master planning, capital projects)

Wilson

Manage leadership teams to assure execution of all site manufacturing and packaging activites in support of compliance, financial and customer service goals.Interface with site support groups (Quality Assurance, Technical Services/Validation, Engineering/Maintenance, Supply Chain) to assure alignment with Operations requirements.Participate in development and execution of strategic site initiatives (Quality compliance/FDA readiness, site master planning, capital projects)

Wilson, Nc

Development and implementation of a robust process for root cause investigations and identification/implementation of CAPA actionsImplement tracking and trending of deviations to identify continuous improvement projects to address process opportunitiesIdentify and support implementation of process and systems changes to improve control and data archival during manufactureFacilitate development and governance of manufacturing teamsProvide technical process support… Show more Development and implementation of a robust process for root cause investigations and identification/implementation of CAPA actionsImplement tracking and trending of deviations to identify continuous improvement projects to address process opportunitiesIdentify and support implementation of process and systems changes to improve control and data archival during manufactureFacilitate development and governance of manufacturing teamsProvide technical process support to manufacturing Show less

Wilson, Nc

Responsibilities included management of transfer, scale up and late stage development for new products as well as technical support for currently marketed products.*Mentored multi-site process improvement team streamlining Pharm Tech Development handoff with Commercial production. *Implemented multi-disciplinary team approach for transfer of new products into the site.*Participated in the development of the Wilson Initiatives Network (WIN) teams, charged with identifying… Show more Responsibilities included management of transfer, scale up and late stage development for new products as well as technical support for currently marketed products.*Mentored multi-site process improvement team streamlining Pharm Tech Development handoff with Commercial production. *Implemented multi-disciplinary team approach for transfer of new products into the site.*Participated in the development of the Wilson Initiatives Network (WIN) teams, charged with identifying opportunities for significant site improvements (systems, procedures etc) and developing/implementing solutions. Show less

Cincinnati Area, Kansas City Area, Puerto Rico

Actively managed a group responsible for scale up and transfer of all new products into the KC site. This included early development work with Research to define the manufacturing technologies/design processes to be utilized at commercial scale, scale up, validation and commercial launch.Provided initial technical evaluation, process fit, mfg feasibility and primary costing for all new 3rd party business.Provided technical support for sub-contracted and third party… Show more Actively managed a group responsible for scale up and transfer of all new products into the KC site. This included early development work with Research to define the manufacturing technologies/design processes to be utilized at commercial scale, scale up, validation and commercial launch.Provided initial technical evaluation, process fit, mfg feasibility and primary costing for all new 3rd party business.Provided technical support for sub-contracted and third party manufacturing including responsibilities as primary Sanofi-Aventis liaison.Primary project leadership responsibilities for at least one transfer program, and secondary responsibility for approximately 4 other transfer programs. Secondary support includes development of all financials, capital and expense funding requests and tracking, protocol authoring and process design/engineering support.Preparation and/or review of documentation required for submission filing. Show less