Tom Scott Email & Phone Number

Manchester, England, Gb

Manchester, England, Gb

Principal Scientist | Analytical Development | Cell Therapy | GMP Compliance- TIL Therapy Release Assays Development: Led the end-to-end development and GMP-compliant validation of release assays for TIL cell therapies, progressing from early phase through to BLA readiness whilst authoring global CMC submissions.- Authored and supported approvals of INDs, IMPDs, and Investigator-Initiated Trial (IIT) submissions to regulatory authorities (FDA, MHRA, NMPA), driving compliance and facilitating the initiation of global clinical trials.- QC Subject Matter Expert (SME): Provided QC oversight on routine drug product (DP) testing, managing deviations, OOS/OOT investigations, and data trending to ensure adherence to stringent regulatory requirements.- Method Validation & PPQ Readiness: Actively contributed to PPQ and method validation, strengthening regulatory milestone achievements and supporting future BLA submissions.

Senior Scientist | Analytical Development | Method Transfer | - Established and managed an Analytical Development (AD) laboratory, leading a team to develop and implement innovative, GMP-compliant analytical methods within a dynamic environment.-Led the development and technology transfer of analytical methods from AD to GMP QC, aligning with regulatory standards (ICH Q2 (R2), ICH Q14, CLSI H62) to ensure robustness and readiness for IND/IMPD submissions.Achieved a 60% reduction in analytical resource requirements by optimizing workflows and implementing lean strategies. Directed a high-throughput facility, maintaining stringent data integrity, HTA, and SHE compliance.Streamlined global shipment coordination with supply chain and laboratory teams, creating SOPs and work instructions to enhance sample management efficiency.

Manchester, Gb

- Established a GCP-compliant flow cytometry service to support Phase I clinical trials, contributing to the success of high-value projects. Collaborated with external sponsors to validate critical assays and streamline workflows, ensuring efficient delivery of clinical trial outcomes.- Led the validation of FCS Express v7 Clinical Software (IQ/OQ/PQ), implementing workflows for data management and analysis.

Indianapolis, Indiana, Us

Technical Lead | Project Management | GLP/GCP Compliance | Flow Cytomety- Directed cross-functional collaboration and technical discussions between contractors and sponsors, ensuring robust project management and on-schedule data delivery across high-priority projects.- Acted as the primary technical lead for sponsor interactions, overseeing GLP/GCP compliance and efficiently resolving technical queries to ensure smooth collaboration, particularly during OOS/OOT investigations.- Flow Cytometry Expertise: Led the design, validation, and transfer of multi-colour flow cytometry assays, independently managing end-to-end project timelines to meet rigorous delivery targets.

Indianapolis, Indiana, Us

- Oversaw technical and operational aspects of multiple sponsor-led projects at Envigo, acting as the primary liaison to ensure seamless project delivery and high-quality results.- Expert training of new team members to uphold quality standards, providing expert technical reviews of sponsor data to ensure accuracy and compliance.

Indianapolis, Indiana, Us

Flow Cytometry Assay Development: Designed and optimized cell-based and in vitro flow cytometry assays (e.g., proliferation, receptor occupancy, T cell subset quantification) to ensure robust performance in clinical trial support.

Indianapolis, Indiana, Us

Pre-clinical and clinical BSL2 sample analysis on diverse specimens including blood, PBMCs, bone marrow and solid tissues.

London, Gb

Development of an imaging flow cytometry assay to measure the effects of anti-cancer drugs on cell cycle functions.

Master Of Science (Msc), Bioscience Technology

Bachelor Of Science (Bsc), Biochemistry