Working under the trusts Pharmaceutical Quality System, the post holder will use their specialist knowledge in Good Manufacturing Practice (GMP) to maintain compliance with regulatory standards and drive continuous improvement.
The job will include review and oversight of activities undertaken in both Production and Quality Control groups within the ATMP manufacturing unit, and the preparation of records for authorisation. Deviation management is a key component, using specialist knowledge to develop informed and reasoned decisions regarding the disposition of products and tests.
• You will ensure adequate maintenance and supervision of equipment, and ensure compliance with Planned Preventive Maintenance (PPM), coordinating with company engineers to maximize the correct operation of essential equipment.
• Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the Pharmaceutical Quality Systems (PQS), such as: how to proceed during technical failures; PPM; Quality Control assessments; technical decisions; suitability of material for manufacture; analysis of anomalous results.
• Monitor and control the production environment to ensure that standards of cleanliness and hygiene are maintained. Provide trending data used to set alert limits for monitoring control of the environment.
• Undertake product quality review to ensure that specifications for products are under control, using Six-Sigma analysis, and provide solutions to gain further control where necessary.
• Work unsupervised managing production and analytical deviations, making informed decisions relating quality systems. You will independently undertake specialist Validation and Qualification for the GMP Unit facilities and equipment as delegated by the Head of Advanced Therapy Production.
• Provide day-to-day professional supervision and practical training for production and quality control activities and ongoing supervision of support staff, and new and junior staff.
The Advanced Therapies Manufacturing Unit (ATU) is co-located with the Clinical Research Facility (CRF) at Guy’s Hospital on the 15thfloor of the tower. The ATU is purpose built for the manufacture of Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue engineered products for early-phase clinical trials or as Specials. It is used for both commercial and non-commercial collaborators as well as departments within GSTT to manufacture ATMPs related to trials undertaken in the CRF and at trial sites across the UK.
Professional Responsibilities
• Responsible for deliveringa highly specialist clinical technical service by leading and managing the quality assurance for manufacturing of cell therapy and gene therapy products for the clinical needs of participants on current and future clinical trials, as delegated by the Head of Advanced Therapy Quality.
• Working with the core facility team, be responsible for ensuring that quality exception investigations, preventative actions and change control procedures are completed effectively and within agreed timelines.
• Take professional responsibility for specialist validation activities, including installation and operational qualifications, and ongoing revalidation in accordance with the Unit’s validation master plan. Authorisation of validation reports.
· Ensure that records of manufactured and tested products are made according to authorised quality standards. You willlead as a specialist quality assurance officer
· Manage the review and acceptance or rejection of raw materials and suppliers of materials and services, keeping an up-to-date review of internal quality systems used to assist in this management.
· Take a lead in the qualification of outsourced activities, including audits of contract acceptor quality control sites, and third parties undertaking licensable activities.
• Responsible formaintaining an up-to-date knowledge-base while demonstrating advanced competencies through a personalised Continued Professional Development portfolio.
• Capable of working independently and as part of a team of clinicians, scientists and regulatory personnel. An ability to provide and receive complex scientific information is required, as is the ability to make concise and accurate input to regulatory submissions. Therefore, you will have good organizational and communication skills with proven record of scientific achievements.
• Required to work with users of the GMP Unit to develop continuous quality improvement through a system of self inspections, and supplier and service provider audits.
• Report result outcomes and provide specialist advice to clinicians, investigators and scientists in clinical development.
• Contribute to the development of this specialist service through technical transfer and process development of novel Advanced Therapy Medicinal Products (ATMPs) within the BRC GMP Unit. You will take responsibility for developing and implementing independently controlled documents: Product Specification Files, Batch Manufacturing Records and Standard Operating Procedures (SOPs) for Production activities in the GMP unit.
Management and Leadership Responsibilities
• Communicate with colleagues about specialist complex manufacturing procedures, explaining complex and sensitive information such as: results to clinicians and other service users; advising clinicians over appropriate production methods to use; undertaking interpretation of results related to the organisation. You will bring innovation and development to the role, ensuring that the service provided by the Unit remains world-leading.
• Disseminate research and specialist technical knowledge. You will attend and lead in presenting at R&D meetings, seminars and national or international meetings where deemed appropriate.
• Plan and prioritise the specialist quality assurance service workload, liaising with other departments, and suppliers in relation to manufacturing and testing ATMPs. You will interact with the Unit’s capacity planning system to ensure the smooth running of the Unit. You will be required to design complex activities with specialist technical services many months ahead.
• Work unsupervised managing production and analytical deviations, making informed decisions relating quality systems. You will independently undertake specialist Validation and Qualification for the GMP Unit facilities and equipment as delegated by the Head of Advanced Therapy Production.
• Provide day-to-day professional supervision and practical training for production and quality control activities and ongoing supervision of support staff, and new and junior staff.
• Make informed decisions relating to manufacturing and testing activities as delegated by the Head of Advanced Therapy Quality tocreate standard procedures that ensure compliance with legislation and Trust requirements. You will be expected to contribute to supervision and training of junior scientific and support staff working in the GMP Unit.
Quality Assurance Process Responsibilities:
• Using specialist experience in Good Manufacturing Practice and the standards for the Quality and Safety of Tissues and Cells for Human Application you will develop production and analytical methods involving closed cell processing, primary cell culture, immunomagnetic depletion (MACS), FACS and proliferation methods during technical transfer to the GMP Unit, and post-authorisation roll-out of production for clinical trials.
• Develop highly specialist knowledge of GMP quality assurance as applied to ATMPs, underpinned by theoretical knowledge and experience of cell biology.
• Work collaboratively with internal and external customers tounderstand a range of complex facts and situations requiring analysis, interpret and compare ranges of options to facilitate process development within the GMP Unit to optimise the process under GMP conditions and provide data for inclusion in regulatory submissions. You will think strategically, ensuring that the GMP Unit is used efficiently to maximise its utility.
• Work collaboratively with internal and external customers to undertake production and analytical qualification under GMP conditions and provide data for application to the regulatory authorities.
• You will ensure adequate maintenance and supervision of equipment, and ensure compliance with Planned Preventive Maintenance (PPM), coordinating with company engineers to maximize the correct operation of essential equipment.
• Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the Pharmaceutical Quality Systems (PQS), such as: how to proceed during technical failures; PPM; Quality Control assessments; technical decisions; suitability of material for manufacture; analysis of anomalous results.
• Monitor and control the production environment to ensure that standards of cleanliness and hygiene are maintained. Provide trending data used to set alert limits for monitoring control of the environment.
• Undertake product quality review to ensure that specifications for products are under control, using Six-Sigma analysis, and provide solutions to gain further control where necessary.
• Computer competency in quality management software is essential.
• Operate within the Pharmaceutical Quality System: In reviewing temporary changes, you will assess the impact of a change on the manufacturing or testing process prior to its implementation. You will report deviations through Quality Exception Reports to line managers. You will undertake Preventive Actions and Change Controls to rectify exceptions and implement audit and inspection findings.
• Where directed or delegated by the Head of Advanced Therapy Quality, you will develop specific, accurate, precise and robust specialist Quality Control assays to be used following cell and gene therapy production.
· Assist in the management and monitoring of Quality Assurance and Quality Control activities,ensuring that agreed quality standards of service are maintained. You will enable preparation of quality data to be used in the certification of ATMPs.
Documentation Responsibilities:
Using your specialist knowledge you will undertake the development and generation of:
• Unit-specific SOPs and policies relating to quality assurance operations. These must comply with GMP and the Unit’s manufacturing licence.
• Product-specific SOPs and batch-specific documentation for the manufacture of ATMPs.
• Product Specification Files or Preparation Process Dossiers for cell therapies.
· Undertake documentation control procedures, using database systems to track GMP documentation.You will work autonomously to Standard Operating Procedures and protocols.
This advert closes on Wednesday 1 Jan 2025