Senior Production Scientist

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Job title: Senior GMP Production Scientist

Reporting to: Production Lead

Department: GMP

No of Direct reports: 2 +

Location: Bristol

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.

The Senior GMP Production Scientist will be responsible for routine operations in eXmoor’s GMP production suites & take the lead role for establishing GMP Production for a varied range of ATMP clinical products in the eXmoor GMP facility.

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 GMP manufacturing career.

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 of 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 Scientists 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.

This is a generic Job Description for Senior GMP Production scientists in our GMP production team, leading GMP manufacturing in cell culture/fermentation or downstream purification and supporting GMP fill/finish.

• 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…