GMP Production Manager

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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.

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.

Main areas of responsibility / key duties:

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.

People:

• You will recruit, train, develop & lead production staff to meet planned production needs and departmental budgets and establish a motivated, capable team.

Training:

• You will develop and deliver the required training of production personnel and non GMP eXmoor personnel (as required), ensuring training is maintained and adapted as required.

Production Facility:

• You will be responsible for all aspects of the facility (including maintenance, operation, qualification, validation, material storage and waste) ensuring all are managed in compliance with the facility’s stated procedures and standards.
• You will implement procedures in line with the Contamination Control Strategy that maintain facility hygiene, adapting appropriately to environmental monitoring results to maintain control

Production Processes:

• You will write, approve and ensure the implementation of SOPs for all activities within the facility. These SOPs must comply with GMP and the Facility’s manufacturing licence.
• You will ensure that production records are evaluated and signed by authorised personnel before they are sent to the Qualified Person (QP) for review.
• You will ensure that all production validations are complete and up to date; including validation of aseptic procedures by media simulation.
• You will develop the GMP technical transfer processes for manufacturing process to be transferred to/ from eXmoor Process Development and Client
• You will work in conjunction with the Quality Manager to develop, maintain and communicate product specifications, including starting materials, in process testing specifications, intermediates, bulk drug substance and final filled drug product quality control specifications and testing schedules.

Documentation:

• You will ensure all required documentation across all steps of production are recorded, evaluated and personally authorised and maintained in line with the manufacturing licences.

Production Planning:

• You will lead and manage all aspects of the production planning including resource, budget, progress reporting and…