Job title: GMP Production Manager
Reporting to: Head of GMP
Department: GMP
No of Direct reports: 3+
Location:​Bristol

SUMMARY:

eXmoor helps clients with their manufacturing of cell and gene therapies (CGT) and biopharmaceuticals. We provide; (1) translation consultancy to close the gap between R&D and clinical manufacture, (2) process development services from our wet labs in Bristol (3) capital project design through to licensing and (4) GMP manufacturing for early phase clinical trials.
The GMP Production Manager will be responsible for establishing the GMP production team and taking a lead role in the operation of the GMP production suites.
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.
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JOB DESCRIPTION:

The GMP manufacturing facility is capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The facility covers two technical areas (Process/ Analytical Development & GMP clinical phase production with 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 GMP Production Manager will lead and develop the GMP production team and will be responsible for leading the day-to-day management, operation, scheduling and administration of the GMP facility ensuring that it is operated and maintained as required by the facility’s licences.

ESSENTIAL QUALIFICATIONS & EXPERIENCE:

• MSc in Life Science or BSc with relevant years industry experience or equivalent experience
• Considerable experience (5 years plus) of managing GMP clean room facilities, production, facility and equipment qualification, quality and GMP documentation.
• In depth understanding of legislative framework of MHRA, HTA and H&SE in Good Manufacturing Practice as applied to small scale biopharmaceutical production for clinical trials.
• Significant experience in a supervisory or management role. This includes the ability to lead, develop, motivate, and organise a small team.
• Proven experience of managing complex production schedules and ensuring the implementation of operating procedures and efficient record keeping.
• Strong project management experience
• In depth understanding and experience of the following processes:
• ATMP manufacture of viral vectors from 50L to 2 x 200L scale (e.g., Fermentation to 2 x 200L, purification, and Fill/Finish)
• In depth understanding and experience of the following unit processes:
• ​50 to 200L single use bioreactors, DSP chromatography systems, micro and ultrafiltration, hand filling or semi-automated fill finish systems into vials
• Resilience and flexibility; able to contribute innovatively to solving process development problems.

DESIRABLE QUALIFICATIONS & EXPERIENCE:

• In depth understanding and experience of the following processes:
• Autologous cell therapy processes (e.g., purification, culture, expansion, and genetic modification using viral vectors of regulatory T cells and Dendritic cells)
• In depth understanding and experience of the following unit processes:
• CliniMACS separations, bench scale centrifugation and density gradient centrifugation, cell culture and expansion in T flasks
• Knowledge of Good Laboratory Practice (GLP) and routine in-process and QC assay techniques such as HPLC, PCR, sterility testing, mycoplasma testing, ELISA, SDS PAGE

Manufacturing Licence:

• You will be named as Production Manager on the GMP Facility’s Manufacturing Authorisation, responsible for leading the GMP team & qualification of the facility, equipment and processes.
• ​You will ensure that products are produced and stored according to authorised specifications.