Kerry H. Email and Phone Number

• Perform formulation development and process development operations in accordance with cGMP standards (where applicable)• Record critical data and complete batch records• Comply with standard operating procedures• To provide leadership, training, coaching and mentoring to the junior members of the team• Responsible for process development, scale up and tech transfer activities in compliance with cGMP standards and the Quality Management System• Contribute to the implementation of process and operational changes in process development to streamline the flow of information and product knowledge from formulation development to manufacturing• Application of DoE knowledge into process development studies• To write reports associated with process development and optimisation project activities• Ensure that all work is conducted in accordance with Health and Safety policies• Support Project Managers, Group Heads and the Business Development Team in assembling quotations for Clients within the agreed timeframe• To manage the day-to-day activities of a team conducting process development activities• To ensure that projects are scheduled accordingly to deliver to expected timeframes• Maintain knowledge and awareness of the latest developments and best practice in area of expertise and seek to apply within the company• To communicate with clients in an effective, proactive and appropriate manner• Able to effectively present information and respond to questions from peers, management, suppliers and customers• Constantly strive to develop and support a culture of Continuous Improvement to improve operations, streamline work processes, decrease turnaround times and improve quality• Support the Management team by assisting the delivery of the internal research programme• Manage the team training matrix and assessing training requirements of the Product Development team• Writing and updating training documentation to ensure training packages are fit for purpose

• Microbiology SME for the ADC site• Management of a small team of Microbiologists (4)• Training and coaching of the QC Microbiology team (Practical and Documentation)• Reviewing training records and assessing training requirements• Writing training packages• Environmental Monitoring (Grade C and D areas) – Viable and non-viable air particles and surface sampling• Bioburden validation and testing using membrane filtration techniques• Endotoxin testing using EndoScan MCS system• Growth Promotion testing on solid culture media• Plate reading – Bioburden, Growth Promotion and Environmental Monitoring plates• Identification of Bacteria, Yeast and Mould to species level using a variety of techniques (Gram Stain, Oxidase, Staphylase, Vitek 2)• Assisting with the implementation of a new Quality Management System• Writing, Reviewing and Updating SOP’s and TM’s• Reviewing data generated for compliance (testing, equipment, calibrations and Environmental Monitoring)• Investigating Deviations and OOS/OOT results and finding the Root Cause• Initiating and actioning CAPA actions• Initiating and actioning the Change control process• Controlling of Stock Levels• Recruitment of staff• Conducting 1:1 meetings and Performance Reviews• Implementation of the Routine Environmental Monitoring program• Writing and reviewing Environmental Monitoring trending reports• Writing and reviewing validation protocols and reports

Overseeing a team of 10-12 techniciansReading plates and reporting of resultsProducing customer reports (Cof A's)Helping with the implementation of new Quality systemReviewing and updating SOP and Test methodsChange control, CAPA, Deviations, OOS reportsDeputising for the Laboratory Manager

• Routine Microbiological Testing • Performing routine calibrations of equipment • Plate Reading (routine testing & environmental surveys)• Identification of Bacteria to species level using a variety of techniques• Environmental Monitoring (Sterile and non-sterile areas)• Sterility, Bioburden & Endotoxin testing• Sampling and testing of steam, WFI and purified water• Use of biological indicators and testing of spores• Deputising for team leader in their absence• Training, coaching & mentoring other members of the team• Liaising with other departments & external customers • Attending quality improvement meetings• Releasing batches of product when testing complete• Passing completed sterile & non-sterile surveys using a LIMS system• Conducting internal audits & code red meetings• Writing environmental trending & revalidation reports • Investigating procedural non-compliances & OOS deviations using a Q-pulse system• Reviewing and updating SOP’s, STM’s, MPM’s etc.

• Implementation of PCR & Methodology• Routine Microbiological Testing• Reading Plates & Identification of Pathogenic Organisms• Environmental Monitoring• Controlling of Stock Levels• Updating Databases & Document Changes• Conducting Internal Audits & Risk Assessments• Active Member of HACCP Team

• Operating Injection Moulding Machines• Assuring Quality • Packing Plastic Food Packaging• Testing of Finished Goods for Size, Visual, Fit & Function

• Operating Injection Moulding & Assembly Machines• Assuring Quality • Packing Plastic Goods

• Preparation of Media• Taking Samples & Environmental Swabbing• Routine testing & Reading Plates• Writing SOP’s & STM’s

• Allocating Work & Meeting Deadlines • Supervising & Training Technicians• Reading Plates & Reporting Results• Testing Food Samples for Environmental & Pathogenic Bacteria• Liaising with Media Prep & Sample Reception

• Testing of Food & Environmental Samples• Preparation of Media & Cleaning of Glassware