Professional / Clinical responsibilities Lead in the testing of clinical grade gene and cell therapy products as determined by the clinical need of participants on current clinical trials as delegated by the Head of Advanced Therapy Quality. To ensure that the products tested, documented and stored according to product specification and quality standards, and regulatory authorisations. Management and Leadership responsibilities Attend and lead in presenting research and specialist technical knowledge at: lab meetings, seminars and national or international meetings where deemed appropriate. Share with others research and specialist technical knowledge related to the organisation, running and maintenance of the GMP unit. Work independently to undertake specialist tests and make informed decisions relating to products manufactured in the GMP Unit. Work independently to undertake specialist Validation and Qualification for the GMP Unit and its Equipment as delegated by the Head of Advanced Therapy Quality. Testing Responsibilities: Using specialist experience in cell manipulation and processing for clinical use develop testing methods involving: flow cytometry; proliferation methodologies; nucleic-acid techniques; standard phamacopoeial methods for sterility, endotoxin, and mycoplasma detection. To work collaboratively with internal and external customers to undertake assay validation work within the GMP Unit to optimise procedures under GMP conditions and provide data for application to the regulatory authorities. To work collaboratively with internal and external customers to collate test data within the GMP unit to finalise the analytical procedure under GMP conditions and provide data for application to the regulatory authorities. To test cellular therapies under GMP conditions for use in clinical trials or as directed by a commercial organisation as the named contracted manufacturer. Maintain, operate, and clean the GMP Units Equipment and facilities in compliance with Units defined procedures and standards. Qualify, process validate and re-validate equipment and GMP procedures successfully and on schedule according to the Units Validation Master Plan. Monitor and control the GMP Quality Control environment to ensure that standards of cleanliness and hygiene are maintained. Ensure all waste generated is subject to appropriate management and disposal. Quality Assurance Responsibilities Where directed or delegated by the Head of Advanced Therapy Quality assist in Quality Assurance activities relating to allocated projects, including Product Quality Review, and statistical analysis of compiled results. Take on delegated responsibility for quality review of Batch Manufacturing Records and other production records in support of certification and release of gene and cell therapy products. Lead laboratory investigations relating to out of trend and out of specification results. Manage deviations appropriately using quality assurance tools such as planned deviations, change control systems and quality exception reporting and investigations. Documentation Responsibilities: Using specialist knowledge, write SOPs relating to specific GMP Unit operations. These SOPs must comply with GMP and the Units manufacturing licence. Issue documents through the Units Q-Pulse document control systems. Using specialist knowledge, undertake the development and generation of product specific SOPs and batch specific documentation. Using specialist knowledge, undertake the development and generation of Product Specification Files for manufacture. Information management responsibilities Play a major role in generating data and for the application to the regulatory authorities for Clinical Trial Authorisation. Actively interpret data and participate in writing up the results of the project for publication. Use specialist knowledge to archive and store appropriately and securely information in accordance with Data Integrity policies and procedures.