Working within the Design Operations Team for Dry Powder Media manufacture

Specializing in project validation whilst continuing to support the routine validation schedule.Additional responsibilities include acting as a technical consultant on chemical and biochemical issues, and audit support as SME for a number of processes.

Part of the validation team that was responsible for qualification of the dry powder manufacturing facility completed at the Irvine site in 2015. Preparation and execution of validation documentation within tight project schedules, whilst ensuring routine validation responsibilities are maintained to facilitate liquid media and dry powder media manufacture. Oversight of external contractors during equipment installation and testing. Subject matter expert on a variety of manufacturing equipment. Routine verification of supporting services (e.g. HVAC, steam and water systems). Temperature mapping of controlled storage equipment and areas. Assessment of all new dry powder media formulations ensuring validated processes remain uncompromised.

Responsible for execution and management of all validation activities on the Gillingham site. Interact with customers and governmental agencies to ensure validation requirements are met and implemented, to meet business needs.

Manufacture small molecules and APIs in a cGMP laboratory up to 20L scale, using fixed vessels and dedicated glassware. Manage and mentor a team of chemists and deputise for team manager during periods of absence, liaising with site and project management to ensure projects are completed on schedule. Qualify, calibrate and maintain equipment for use within the cGMP department. Develop and validate processes for custom manufacture. Provide support for plant manufacturing processes (up to 1600 litre scale).Achievements included –• Maintaining a critical equipment database to track calibration status and ensure equipment is maintained and suitable for use.• Purchase of bespoke electronic chart recorders at 25% of the cost of off-the-shelf instruments to reduce equipment related deviations, saving considerable resource.

Act as primary client contact for all aspects of the project within a pharmaceutical manufacturing environment. Perform chemistry and manage chemists involved in PR&D and cGMP projects. Generate batch processing documentation, plan equipment and order materials required for synthesis on a JEJIT basis. Schedule and chair project review meetings. Check that relevant analytical support is maintained to enable project to move forward. Ensure customer reports are generated in a timely manner, and that all key learning points are documented at the end of the project. Train chemists how to safely scale up processes in order to manufacture ‘first kilo’ quantities of novel pharmaceuticals within exacting deadlines. Maintain equipment and coordinate service schedules to minimise downtime during all manufacturing campaigns. Transfer processes to full-scale manufacture up to 16,000L.Competent to handle air and moisture sensitive reagents, highly toxic inorganics (e.g. cyanides) and high potency compounds on process scale. Proficient in routine analytical techniques (1H NMR, LC-MS, GC, IR etc).Achievements included –· Implementable savings of over $1M by applying Lean and Six Sigma approaches to key API manufacturing methods at SAFC Pharma, Arklow.· Reduction of utilities costs for the Manchester site by driving energy saving initiatives.· Development of a searchable user-friendly COSHH database utilising Microsoft Excel and VBA.

Work on custom synthesis projects up to multi-kilogram scale as part of a team of chemists. Liaise with project leader and clients to ensure project deliverables are met on time. Deliver training to chemists on topics based around scale-up and hazard evaluation. Manage laboratory to ensure high standard of housekeeping is maintained.Achievements included –· Set-up of Reaction Calorimetry equipment and instigation of hazard evaluation training at the Manchester Site.· Purchase of Cuno filters to ensure safe filtration of reactive metal catalysts and clarification of API solutions.