Luke Cutmore

I coordinated the GMP compliant production of advanced therapy medicinal products (ATMP). I lead a team of Biotechnologists through aseptic production activities in a clean room facility, liaising with support departments (QC, QA and supply chain) to ensure successful clinical release of ATMPs to our clients. • Review, update and improve Batch Manufacturing Records and SOPs. • Involved in continuous improvement initiatives & development of production processes. • Subject Matter Expert (SME) for all manufacturing documentation and processes. • Acts as the primary point of contact between QC, QA and operations to ensure manufacturing runs to schedule. • Support staff in their professional development, including formal appraisals, 1-1 feedback sessions. • Delivery and manage training within the manufacturing department. • Health and safety representative for manufacturing department. • Investigate and report quality incidents/deviations e.g. OOT/OOS results. • Implement CAPAs/Change controls. • Executing validation protocols. • Perform holistic review of batch production activities and batch records for clinical release with involvement from QA/QP after collating all relevant documentation. • Manage external contractors. • Responsible person for on-call facility monitoring system.

Proficient in mammalian cell culture, media preparation and downstream processing (e.g. chromatography, ultra/diafiltration,) of multiple LentiVector® based APIs used in gene/cell therapy in a clean room environment to cGMP. • Performing work under aseptic conditions. • Preparing, cleaning and maintaining the GMP compliance of the facility. • Performing viable and non-viable environmental monitoring. • Completing Batch Manufacturing Records throughout the manufacturing process. • Involved in continuous improvement initiatives & development of production processes. • Investigating out of specification results and reviewing procedures. • Deviation management, CAPA and Change control implementation. • First aid trained.

Responsible for prioritising, managing and planning the work of a shift team during Active pharmaceutical Ingredient (API) manufacture ensuring work is completed to a given deadline under strict GMP guidelines. Work involves production of commercial and development API’s which can include validation of processes and equipment for future commercialisation. • Management and review of GMP documentation • Delegation of workforce to specific projects within two different pilot plants • Coach and mentor team members to unify quality and ensure the competence level is raised • Strive to improve plant processes through the implementation of change controls • Built strong relationships with other departments that support production • To ensure team adheres to Quality, EHS, housekeeping, and documentation standards that are expected of production staff • Deliver extensive handover to incoming production team • Carry out performance related reviews on a biannual basis with shift team and set objectives for each individual

Experienced in operations of Pilot scale Reactor vessels and isolation equipment for use in batch chemical manufacture to GMP standards • Taken on additional Environmental, swabbing and dust monitoring roles which involved extensive use of HPLC systems and analytical techniques

worked in the alcotex development laboratory in association with my MSci degree • Implementation of project through the lab scale up to pilot scale • Worked with the technical and sales teams to aid in providing knowledge to customers