GMP Production Manager

Job title:GMP Production Manager

Reporting to:Head of GMP

Department:GMP

No of Direct reports:3+

Location: ​Bristol

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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.

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 forecasting.

Procurement:

• You will work with the Quality Manager and eXmoor Procurement team to ensure the procurement and storage of key supplies occurs in line with the production schedule and procurement processes.

Service Development:

• You will work with the eXmoor Process Development Team to develop fit for purpose processes that suit the equipment in the Facility.

Pharmaceutical Quality:

• You will monitor compliance with GMP within production.
• You will take a lead role in Management reviews of process performance and product quality.
• You will advocate for & lead continuous improvement.
• You will escalate quality issues quickly and effectively to the appropriate leadership levels

Projects:

• You will be a key member of teams working with GMP clients and will contribute to the technical discussions during project team & client meetings.
• You will support project management with any scope changes when required.

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 be responsible for ensuring that the highest level of safety compliance is in place within the GMP facility
• You will comply with and ensure that your team complies with, GMP and lab documentation including Risk assessments, SOPs, COSHH forms, lab notebooks and records.​

Person Specification:

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​

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