They have a requirement for a Head of GMP Operations to manage the current GMP facility as they transition to the new one. This individual will manage a team of 10 with a view to grow the production team to around 40 over the next 3-4 years. The Head of GMP Operations will help establish and develop the GMP production team and will be responsible for the day-to-day management, operation, scheduling and administration of the GMP facility.
On offer for the Head of GMP is a competitive salary and benefits package with room for career progression.
Main areas of responsibility / key duties for the Head of GMP:
- Manufacturing Licence: Named as Production Manager on the GMP Facility’s Manufacturing Authorisation, responsible for leading the qualification of the facility, equipment and processes from detailed design through to MHRA Licensing and beneficial operation and subsequent inspections.
- Ensure that products are produced and stored according to authorised specifications.
- People: Recruit, train, develop & supervise production staff to meet planned production needs and departmental budgets and establish a motivated, capable team.
- Training: Develop and deliver the required initial and continuing training of production personnel, ensuring training is maintained and adapted as required.
- Production Facility: Ensure all aspects of the facility (including maintenance, operation, qualification, validation, material storage and waste) are managed in compliance with the facility’s stated procedures and standards.
- Implement procedures in line with the Contamination Control Strategy that maintain facility hygiene, adapting appropriately to environmental monitoring results to maintain control.
- Production Processes: 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.
- Ensure that production records are evaluated and signed by authorised personnel before they are sent to the Qualified Person (QP) for review.
- Ensure that all production validations are complete and up to date; including validation of aseptic procedures by media simulation.
- Develop the GMP technical transfer processes for manufacturing process to be transferred to/from Process Development or out to the Client
- Work in conjunction with the Head of Quality 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: 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: Manage all aspects of the production planning including resource, budget, progress reporting and forecasting.
- Procurement: Work with the Head of Quality and Procurement team to ensure the procurement and storage of key supplies occurs in line with the production schedule and procurement processes.
- Service Development: Work with the Process Development Team to fit for purpose develop processes that suit the equipment in the Facility.
- Pharmaceutical Quality: Monitor compliance with GMP within production. Participate in Management reviews of process performance and product quality. Advocate continuous improvement. Escalate quality issues quickly and effectively to the appropriate management levels
Essential Qualifications & Experience:
- MSc in Life Science or equivalent
- 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 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