Senior GMP Production Scientist

at  eXmoor Pharma Concepts Ltd

Job title: Senior GMP Production Scientist
Reporting to: Head of GMP
Department: GMP
No of Direct reports: 2 +
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 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.

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&GT
• ​purification of vectors, plasmids, whole cells,
• aseptic filling
• multi-product facilities
• understanding GMP
• 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.

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.