Senior Analytical Services; AS Scientist

Summary

eXmoor Pharma is the only integrated cell and gene therapy CDMO with over 20 years of consultancy expertise embedded across every stage of the CMC journey — from early‑phase strategy to process development, GMP manufacturing and commercialisation. We provide comprehensive support across Viral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies. This integrated model enables seamless progression from early‑phase strategy through to commercial readiness.

This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants and engineers. You will work on a wide range of Client projects in a rapidly growing business whilst developing your quality management career.

The GMP manufacturing facility will be capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The eXmoor facility will comprise three technical areas (Process Development (PD), shared AS including QC & GMP clinical phase production), both working closely together such that processes developed in the PD/AS area will be transferred at scale to the GMP suites and GMP QC.

The Senior AS Scientist will be responsible for managing and maintaining the GMP QC analytical function ensuring the laboratory and QC testing for materials and products meets its requirements under the MIA (IMP) licence and ensuring support for the AS function, whilst maintaining appropriate segregation between the two activities.

• You will supervise GMP AS Scientists in their role.
• You will carry out GMP analytical testing for raw materials, in-process and final product & stability test samples.
• Within the shared Analytical Services Department, you will manage the qualification/validation of the assays used in QC, ready for MHRA Licensing and beneficial operation and subsequent inspections.
• You will support Head of Quality in ensure that all QC validations/qualifications are complete and up to date.
• You will work with the wider Analytical Services Team to ensure assays are developed that are ‘fit for purpose’.
• You will control and supervise systems for the management of tests and reference/retain samples for materials and products.
• You will write and approve QC sampling plans and specifications.
• You will lead the GMP technical transfer processes for GMP QC, to be transferred to/from eXmoor Analytical Services or out to the Client.
• You will manage QC materials and supply.
• You will manage outsourced QC activities with third parties.
• You will ensure any Quality incidents raised within QC are managed and dealt with appropriately.
• You will perform laboratory investigations and out of specification investigations to GMP standards.
• You will support the site Pharmaceutical Quality System including input into investigations and/or CAPAs.
• You will support both internal and external audits including writing reports, agreeing CAPA and following these up as required.
• You will review and approval of risk assessments and validation documentation as required.
• You will conduct Product Quality Reviews as required.
• You will manage and report on environmental monitoring trends ensuring compliance with GMP standards are being maintained.

• You will ensure all aspects of the GMP QC laboratory area (including maintenance, operation, qualification, validation, material storage and waste) are managed in compliance with the facility’s stated policies and procedures, and the MIA (IMP) licence.
• You will be responsible for the implementation of SOPs for all activities within the QC laboratory function. These SOPs must comply with GMP and the Facility’s manufacturing licence.

• You will ensure principles of Good Documentation Practice are maintained within QC.
• You will review and approve QC operational SOPs prior to implementation.
• You will create, review and approve QC GMP SOPs, test methods/report forms and specifications.
• You will quality review and approval of maintenance, calibration and validation activities.

• You will support the training and development of GMP QC staff.
• You will have responsibility for providing training in QC methodology and…