Advanced Therapy Quality Control Scientist

Job overview

The Good Manufacturing Practice (GMP) Unit at Guy’s Hospital was formed to accelerate the translation of novel approaches to the prevention, diagnosis and therapy of major unmet diseases relevant to the NHS, and will ultimately contribute to the improvement of patient outcomes. Specialising in developing and manufacturing cell and gene therapies for use in early phase clinical trials, the GMP Unit is looking to appoint a Advanced Therapy Quality Scientist.

Main duties of the job

The field of Advanced Therapy Medicinal Products is expanding rapidly; this post gives the prospective candidate the opportunity to expand their horizons and promote this field. If successfully appointed, you will have gained at least a first degree or equivalent, and will ideally be experienced in developing and / or performing quality control assays for cell or gene therapies. You will support in the quality control of Investigational Medicinal Products (IMP) for clinical trials. You will assist with developing and improving existing quality control methods for testing the purity, identity, functional and safety profile of cell and gene therapies manufactured by the unit. You will play a key role in the quality control of IMP as determined by the clinical needs of participants in current and future clinical trials. You will also assist customers to develop In-Process Quality Control assays. You will work as part of a team maintaining the GMP facilities and equipment in accordance with maintenance and validation programmes.

The successful applicant will operate within and contribute to a GMP Pharmaceutical Quality System including change control, preventive actions, deviation management and document control.

Excellent interpersonal and communication skills are essential, as is the ability to work autonomously and as part of a team within a multi-disciplinary environment.

Detailed job description and main responsibilities

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 Unit’s Equipment and facilities in compliance with Unit’s defined procedures and standards.
• Qualify, process validate and re-validate equipment and GMP procedures successfully and on schedule according to the Unit’s 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 control review of Batch Manufacturing Records and other OSS/OOT 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 Unit’s manufacturing licence. Issue documents through the Unit’s Q-Pulse document control systems.
• Using specialist knowledge, undertake the development and generation of product specific SOP’s 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.