This leadership post runs production in the GMP Unit of the R&D Department at Guy's and St Thomas' NHS Foundation Trust, making small-scale biopharmaceutical products for clinical trials. It covers scheduling and manufacture within the unit's licences and writing its policies and procedures, with quality assurance shared with the Head of Quality. It is distinct for its cell and advanced therapy focus, its named Production Manager role on the MHRA manufacturing authorisation, and line management of production scientists. A postgraduate degree and extensive supervisory GMP experience decide fit.
What the job involves
- Manage day-to-day production, scheduling and administration to the unit's licences
- Ensure products are manufactured and stored to guidelines and fit for intended use
- Lead development and production of current campaigns and new manufacturing processes
- Manage infrastructure, systems and procedures for UK and Trust compliance
- Develop and implement manufacturing policies and standard operating procedures
- Lead line management, recruitment, appraisal and development of GMP production staff
- Establish and maintain the quality management system with the Head of Quality
- Ensure maintenance, operation, cleaning and validation meet the Validation Master Plan and planned preventative maintenance
- Develop and manage production schedules within budget
- Build a pipeline of income-generating manufacturing campaigns
- Support Clinical Trial Authorisation submissions, including the IMPD
- Represent the Trust nationally and internationally on the unit's work
Qualifications
- Postgraduate degree (MSc) in a relevant subject, or equivalent experience
Experience
- Considerable GMP experience managing production, qualification, quality, documentation and complex production schedules
- Extensive supervisory experience leading, developing and motivating production scientists
- Strong project management experience
- In-depth experience of cell therapy processes, such as purification, culture, expansion and genetic modification with viral vectors
- In-depth experience of MACS, FACS, bench-scale and density gradient centrifugation, closed-system cell expansion, and ATMP purification and formulation
- Experience managing a budget
Skills & knowledge
- In-depth knowledge of MHRA, HTA and HSE legislation for GMP in small-scale biopharmaceutical production for clinical trials
- Knowledge of GQCLP, in-process controls and QC assays such as flow cytometry, sterility, mycoplasma, ELISA and NAT/PCR
- Good verbal and written communication, including board-level report writing and presentation
- Strong organisational skills, managing competing demands, and good computer skills
- Commercial awareness, with experience of procurement and contract management
Other
- Resilience and flexibility, with an innovative approach to process development problems
- Well motivated, works without direct supervision and uses own initiative
- Builds good working relationships at all levels and handles confidential information professionally
Nice to have
- PhD or equivalent qualification
- In-depth experience of tissue engineered products
- Dissolution, filtration sterilisation and small-scale manual aseptic filling
- Small-scale chromatography and micro and ultrafiltration
- Experience of computerised document management systems such as Q-Pulse
- Support to expand or modify existing GMP infrastructure
- Experience with 20L disposable bioreactors and hand filling into vials
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Contact Details:
The Methodist Church in Britain Recruitment Team
