Head of Advanced Therapies Production

• Named as the Production Manager on the GMP units MHRA manufacturing authorisation.
• Develop, maintain and manage production schedules in line with the units budget.
• Design, deliver and provide relevant training courses to meet the needs of unit staff and users.
• Develop required manufacturing process for manufacturing campaigns and develop and maintain required documentation and specification files.
• Assist collaborators and users with Clinical Trial Authorisation submissions including the Investigational Medicinal Product Dossier.Conduct procurement in line with GMP requirements and the Trust processes.
• Along with the Head of Quality, ensure that the maintenance, operation, cleaning and validation of the Unit and equipment are completed in compliance with units stated procedures and standards, including obligations in the units Validation Master Plan and Planned Preventative Maintenance plan.
• Establish, implement and ensure adherence to the quality management system.
• Provide line management for key GMP Production staff and lead on recruitment, induction, appraisal, training and development and retention of production staff.
• Represent the Trust at national and international meetings, presenting the Unit and its work, so as to highlight the benefits of using the Unit to the ATMP sector
• Play a key role in developing new business of the unit and building a pipeline of income generating manufacturing campaigns.

Essential

• Considerable experience of managing production, qualification, quality and documentation activities in a GMP environment.
• Proven experience of managing complex production schedules in a GMP environment and ensuring the implementation of operating procedures and efficient record keeping
• Extensive experience in a supervisory role. This includes the ability to lead, develop, motivate and manage a team of production scientists.
• Strong project management experience
• In depth understanding and experience of cell therapy processes (e.g. purification, culture, expansion and genetic modification using viral vectors regulatory T cells, ES Cells and other non-adherent cells).
• In depth understanding and experience of the following unit processes -MACS, FACS, bench scale centrifugation and density gradient centrifugation -Cell expansion in closed systems -Purification and formulation of ATMPs
• Experience of managing a budget

Desirable

• In depth understanding and experience of: -Tissue engineered products
• Dissolution, sterilisation by filtration and small scale manual aseptic filling In depth understanding and experience of small scale chromatography, small scale Micro and Ultrafiltration
• Experience of computerised Document Management systems such as Q-Pulse
• Support to the expansion and / or modification of existing GMP infrastructure

Essential

• 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.
• Knowledge of Good QC Laboratory Practice and routine in-process controls (IPC) and QC assay techniques such as flow cytometry, sterility testing, mycoplasma testing, ELISA, NAT/PCR assays
• Good communication skills both verbally and in written form. Experience of report writing for Board level staff and presentation skills.
• Strong organisational skills with a proven ability to manage competing demands.
• Commercially aware and able to manage procurement, and contracts
• Good computer skills

Essential

• Resilience and flexibility; able to contribute innovatively to solving process development problems.
• Well motivated with evidence of an ability to work without direct supervision and to use own initiative
• Ability to develop and maintain good working relationships with all levels of staff
• Highly professional approach to work, in particular in dealing with confidential information