Senior GMP Production Scientist

Job title: Senior GMP Production Scientist
Reporting to: Production Lead
Department: GMP
No of Direct reports
: 2 +
Location: Bristol

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.

The GMP manufacturing facility is capable of handling a wide range of cell and gene therapies as well as small‑scale complex biologics. The eXmoor facility comprises two technical areas (Process/Analytical Development & GMP clinical phase production, including a small fill/finish capability and all associated QC), both working closely together such that processes developed in the PD/AD area will be transferred at scale to the GMP suites.

The Senior GMP Production Scientist will take responsibility for the day‑to‑day supervision of GMP production teams and production activities along with playing a lead role in the technology transfer of processes from eXmoor’s Process Development Team and clients.

• You will support the tech transfer & scale‑up work within the GMP facility to optimise the procedure under GMP conditions and provide data for application to the regulatory authorities.
• You will be responsible for the supervision of a number of Production Scientists & carry out GMP manufacture of clinical grade ATMP products in accordance with GMP & the Product Specification File.
• You will ensure GMP materials are specified and minimise the risk of any impact on the production schedules and project timelines by supporting procurement.
• You will ensure that work in progress and finished products are produced, labelled and stored according to product specification and quality standards.
• You will develop production methods including closed processing cell culture, downstream purification and fill/finish at varying scales up to 400L.

• Working with the maintenance team you will ensure that the maintenance, operation, cleaning and validation of the Production Equipment are completed in compliance with facility’s stated procedures and standards.
• You will ensure that the appropriate qualification, process validation and regular re‑validations are completed successfully and on schedule.
• You will assist in the monitoring and control of the production environment and ensure that standards of cleanliness and hygiene are maintained.

• You will work as a team to develop and deliver the required initial and continuing training of production & support personnel for production operations, ensuring training is maintained and adapted as required.
• You will take responsibility for coaching and mentoring more junior Scientists.

• You will develop and generate SOPs & Batch Documentation relating to specific GMP facility and manufacturing operations.
• You will play a leading role in generating & reviewing data and for the application to the regulatory authorities for Clinical Trial Authorisation.

• You will conduct your duties to the highest quality standard and in a safe way complying with all policies and procedures and with due care and attention for yourself and your peers.
• You will comply with GMP and lab documentation including Risk assessments, SOPs, COSHH forms, lab notebooks and records.

• You will present data to our clients and take part in the technical discussion during project team meetings.
• You will support project management with any scope changes when required.

• MSc in Life Science / Engineering degree or BSc with relevant years industry experience.
• Considerable experience (3 years plus) of working in GMP clean room facilities, manufacturing ATMP or biological productions for human use.
• Experience in equipment and process qualification.
• Experience with…