Job responsibilities
4. Duties and Responsibilities4.1. Professional / Clinical Responsibilities Responsible for delivering a highly specialist clinical technical service by leading in the manufacturing of immune cell therapy products for the clinical needs of participants on current and future clinical trials or Specials. Assess the suitability of human cells received for manufacture and liaise with senior clinical staff for action or advice if unsuitable. Ensure the correct disposal of cells and/or patient samples in accordance with relevant departmental and governmental policies. Ensure that manufactured products are labelled, documented and stored according to authorised specifications and quality standards. Responsible for maintaining an up-to-date knowledge-base of Immunological products used in Adoptive Cellular Therapy 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. Required to work with users of the BRC Advanced Therapies Manufacturing Unit to develop multicolour phenotyping panels for FACS profiles to allow cell selection and subsequent cell expansion. Required to work with collaborators in developing processes by taking pre-clinical ideas and technology transferring to the unit and ensuring phase appropriate GMP compliance Lead Validation and qualification procedures for processes and equipments used for manufacture of immune cell products3 Provide specialist knowledge of the latest developments within cell and gene therapy manufacturing science and technology Provide specialist knowledge of Immunology of human cells and suggesting continuous process improvement ideas Report result outcomes and provide specialist advice to clinicians, investigators and scientists in clinical development. Take responsibility for developing and implementing independently controlled documents: Investigational Medicinal Product Dossiers, Product Specification Files, Batch Manufacturing Records and Standard Operating Procedures (SOPs) for Production activities in the GMP unit. Ensure adequate maintenance and supervision of equipment, and ensure compliance with Planned Preventive Maintenance (PPM) Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the Pharmaceutical Quality Systems (PQS) Qualify, validate and re-validate equipment and GMP procedures successfully and on-schedule according to the Units Validation Master Plan (VMP) and PQS Hands-on experience operating in an aseptic GMP Unit manufacturing ATMPs will provide you with the skills to meet these developing needs. Be proficient in advanced scientific data analysis. Knowledge of specialist scientific software e.g. R, Flow Jo, Graphpad Prism is desirable Show advanced level knowledge of Immunology in the context of cell activation, growth , functionality and potency of immune cells4.2 Management and Leadership Responsibilities Communicate with colleagues about specialist complex manufacturing procedures, 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. Attend and lead in presenting at BRC meetings, seminars and national or international meetings where deemed appropriate. Plan and prioritise the use of specialist GMP equipment workload, liaising with other departments, and suppliers in relation to manufacturing ATMPs. Interact with the Units capacity planning system to ensure the smooth running of the Unit. Work unsupervised managing production deviations, making informed decisions relating quality systems. Provide day-to-day professional supervision and practical training for production activities and ongoing supervision of support staff, and new and junior staff. When required /able to act as the Deputy for the Production Manager supervising Production staff members, and managing Production schedules. Good communications skills , being able to work with different stakeholders and their project specific needs4 Can-do attitude, flexibility and pragmatic approaches to problem solving is required.4.3 Quality Responsibilities Operate within the Pharmaceutical Quality System: Have an understanding of PQS tools such as Deviation/Change management additionally an understanding of risk assessments is required. Where directed or delegated by the Head of Advanced Therapy Quality, you will help develop specific, accurate, precise and robust specialist Quality Control assays to be used following immune cell therapy production. Assist in the management and monitoring of Quality Assurance and Quality Control activities, ensuring that agreed quality standards of service are maintained.4.4 Documentation Responsibilities:Using your specialist knowledge you will undertake the development and generation of: Unit-specific SOPs and policies relating to and manufacturing operations. These must comply with GMP and the Units manufacturing licence. Product-specific SOPs and batch-specific documentation for the manufacture of ATMPs. Product Specification Files or Preparation Process Dossiers and or IMPDs for cell therapies.4.5 Information Management Responsibilities Play a major role in generating data for the application to the regulatory authorities for Clinical Trial Authorisation (CTA). You will record meticulously all data generated for the CTA submission to GMP standards. Work in compliance with national standards for the safe, secure and confidential processing and storage of patient and laboratory information and when accessing patient information on computer databases. You will be active interpreting data, and participate in writings for publication.4.6 Working Conditions:The role calls for a detail-orientated and highly-motivated individual with the ability develop ex-vivo immune cell culture protocols using specialist data analysis tools. Prolonged concentration is required when processing samples, and operating specialist manufacturing equipment. There will be prolonged work in a clean room. There will be occasional moderate physical effort requirement for sitting and standing in a restricted position for a substantial proportion of time working in Grade A Isolator systems. There will be sitting and standing daily for bench work for long periods, with frequent repetitive movements. You will need excellent highly developed physical skills where accuracy is important; hand-eye co-ordination and accuracy for processing material as well as excellent dexterity for the fine adjustments to specialist equipment.5 Exposure to distressing or emotional circumstances is rare but may occur, with limited patient contact.
