Charles Boyle Email and Phone Number

Working for WuXi Biologics, commissioning, qualifying and Validating existing and new equipment within the Biotechnology industry. Worked on Upstream (Bioreactors, Waves, Centrifuge, SUMs) Downstream (AKTA, Axichrom, UFDF), analytical equipment (Air samplers, HPLC, UV etc). Currently working on Fill/Finish qualifying Lyo, Vial washer, Tunnel, clean rooms etc).

Recruited to be the validation manager for the Annan and Edinburgh sites. Responsible for all validation aspects for the sites. Role involved validation lead for all customer and regulatory inspections. Single point of contact for all commissioning, qualification and validation (including computer system validation) for the site. Role evolved into including writing all cleaning validation protocols and batch documentation.

Recruited to carry out retrospective validation on previous non GMP plant and equipment. Role involved writing VMPs, and writing and executing IQ, OQ and PV protocols. Role also involved writing EQRs and liaising with external contractors to carry out qualification on utilities.

Recruited to provide support and co-ordination for all site validation activities, and provide QA guidance on validation projects. Responsibility for cleaning validation, change control on plant modifications and generating, validation plans, DQ, IQ, OQ , PQ/PV and VSR.

• Promoted and transferred to the Cramlington site. • Implemented key improvement strategies including visual management, identification of clear short term objectives, successful implementation of tracking and trending of specific factors related to downtime and capacity resulting in increased production of key product. • Broke production records for processes in 2 production buildings generating an additional £2m in revenue - £1m contribution.

• Recruited from PharmAthene to lead a multi-functional team of 16 personnel to manufacture pharmaceutical intermediates and final products. • Significantly decreased turnaround times by streamlining the cleaning processes leading to increased production capacity by 50%. • Responsible for the site outside normal working hours, including all health, safety and environmental aspects. Experienced in liaising with emergency services and in coordinating emergency simulations.

Managed process of chemical and analytical transfer of manufacture of vaccines to the United States. Gained valuable knowledge and experience of the Biotechnology industry.

• Led a team of process operators, shift analysts and security personnel to manufacture pharmaceutical intermediates and final products. • Identified and initiated highly effective improvements to significantly increase (50%) throughput in production plant without incurring additional costs. • Improved safety processes on site by creating procedures for dynamic risk assessment and overseeing the successful implementation of these procedures.

• Managed a production building. Effectively managed and monitored budgets for material usage variance and safety. • Initiated and led a highly successful project to reprocess materials designated for waste thus releasing £0.5m in that financial year. • Effectively addressed apathy of operations staff by transforming site culture and attitudes towards business targets through a programme of empowerment and improved communication. • Created and introduced suggestion scheme for improvement of plant operation involving feedback for all ideas offered by staff. • Personally responsible for decreasing cycle times of key processes by 70% through the introduction of Lean tools to the site.

• Responsible for a general purpose production facility, manufacturing intermediates and final products on a campaign basis to tight time constraints. • Managing, commissioning and validating engineering projects including new bromine dispensing system, and new oven room to harvest and dry pharmaceutical products. • 9 month secondment to Singapore, commissioning and validating new processes as part of a technology transfer from the UK.

Working with a team of chemists, developing and optimising chemical synthetic routes for drugs in the development phase.