Senior GMP Production Scientist

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.

Job Purpose:

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.

Main areas of responsibility / key duties:

Production Processes:

• 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.

Production Facility:

• 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.

Training:

• 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.

Documentation:

• 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.

Safety:

• 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.

Projects:

• 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.

Person Specification:

Essential Qualifications & Experience:

• 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 generation of materials risk assessments, materials specifications and procurement to GMP principles.
• Understanding of regulatory & licensing requirements for MHRA in Good Manufacturing Practice as applied to small scale biopharmaceutical production for clinical trials
• Operating within a GMP Quality system including the management of production deviations, change controls and the principle of quality risk management.
• Experience in a supervisory role. This includes the ability to, develop, motivate, and organise a small team.
• Experience of managing production schedules and ensuring the implementation of operating procedures and efficient record keeping.
• In depth understanding and experience of one or more of the following unit operations:
• mammalian cell culture (adherent &/or suspension, up to 400L scale)
• autologous and allogeneic C>
• purification of vectors, plasmids, whole cells,
• aseptic filling
• multi-product facilities
• Resilience and flexibility; able to contribute innovatively to solving processing problems.
• Previous experience with Technology Transfer from Process Development to GMP environments.

Desirable Qualifications & Experience:

• Knowledge of Good Laboratory Practice (GLP) and routine in-process and QC assay techniques for ATMPs.
• Preparation for audits with FDA/MHRA and other regulatory bodies.

Competences Required:

• Organisation, planning and time management
• Oral and written communication skills
• Leadership and teamworking
• Innovation, inquisitiveness, and willingness to learn
• Attention to detail and getting things finished
• Problem solving
• Building constructive relationships and earning respect
• Motivated by growing a bio-technology business in the CGT / biopharmaceutical market
• Proficiency in Office365 (including Word, Excel, PowerPoint).

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