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Principal Scientist with over a decade of experience in analytical development, quality control, and CMC strategy for advanced therapies and biologics. My career has been dedicated to advancing GxP-compliant method development, validation, and technology transfer to support clinical development.I bring a blend of technical expertise and strategic insight, ensuring robust analytical frameworks that meet the rigorous demands of clinical programs and regulatory standards. I excel in leading cross-functional teams and managing complex projects that drive clinical projects from early-phase trials through to BLA readiness.I’m passionate about supporting clinical programs with technical leadership and strategic insight in analytics. I’m currently open to permanent or contract opportunities that leverage my background in GMP analytics, method development, and regulatory strategy to support cutting-edge therapies in biologics or advanced therapies.
Bioanalytical Partners Ltd
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Bioanalytical Partners LtdManchester, England, Gb
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Principal ScientistInstil Bio Nov 2021 - Oct 2024Principal 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 ScientistInstil Bio Nov 2020 - Nov 2021Senior 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.
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Research ScientistMedicines Evaluation Unit Ltd Jan 2018 - Nov 2020Manchester, 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. -
Technical SpecialistEnvigo ++++ Aug 2017 - Jan 2018Indianapolis, Indiana, UsTechnical 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. -
Associate Technical SpecialistEnvigo ++++ Jul 2016 - Jul 2017Indianapolis, 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.
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ScientistEnvigo ++++ Jul 2014 - Jul 2016Indianapolis, Indiana, UsFlow 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.
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Associate ScientistEnvigo ++++ Oct 2013 - Jul 2014Indianapolis, Indiana, UsPre-clinical and clinical BSL2 sample analysis on diverse specimens including blood, PBMCs, bone marrow and solid tissues.
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Placement StudentCancer Research Uk Apr 2013 - Sep 2013London, GbDevelopment of an imaging flow cytometry assay to measure the effects of anti-cancer drugs on cell cycle functions. -
VolunteerLondon 2012 Aug 2012 - Sep 2012
Tom Scott Skills
Tom Scott Education Details
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University Of YorkBioscience Technology -
The University Of ManchesterBiochemistry
Frequently Asked Questions about Tom Scott
What company does Tom Scott work for?
Tom Scott works for Bioanalytical Partners Ltd
What is Tom Scott's role at the current company?
Tom Scott's current role is Principal Scientist | CMC | Analytical Development, Cell Therapy.
What is Tom Scott's email address?
Tom Scott's email address is to****@****igo.com
What schools did Tom Scott attend?
Tom Scott attended University Of York, The University Of Manchester.
What skills is Tom Scott known for?
Tom Scott has skills like Flow Cytometry, Cell Culture, Biotechnology, Biochemistry, Life Sciences, Cell Based Assays, Good Laboratory Practice, Validation, Cell Biology.
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