We are currently looking for a Senior Scientist to lead the quality control of Cell Therapy products including a human embryonic derived product in collaboration with a large pharmaceutical company. As the Senior GMP Production Scientist, you will be responsible for taking the lead role for establishing GMP Quality Control for release testing and stability studies. This post will require someone with extensive flow cytometry experience, particularly with FACSLyric to GMP expertise.
Main duties of the job
The Senior Scientist will be expected to supervise and carry out efficiently the preparation and analysis of ATMPs and to participate in the quality control of cell & tissue medicines. This will include training scientific staff within the department in these procedures.
This will include:
* To assist/lead in the preparation and review of GMP documentation including BMRs, SOPs, Change Control, user requirement specifications, process deviations, and risk assessments to ensure the highest levels of controls and traceability.
* Perform ATMP quality control for clinical trials and ensure all activities are undertaken in accordance with GMP regulatory and quality standards.
* Assist in coordination of QC scheduling activity, labelling, packaging and distribution of starting materials, raw materials and final drug product.
* Assist with coordination activities with QC to ensure appropriate and timely sampling and testing of raw materials, in-process samples and finished product.
* Perform routine maintenance of a QC laboratory environment suitable for the manufacture of ATMPs.
* Assist other users of the CCGTT with flow cytometry activities.
* Co-ordinate external testing activities.
About us
The Royal Free London NHS Foundation Trust is one of the UK's biggest and most innovative trusts. Across three main hospitals, our dedicated army of staff care for over 1.6 million patients, treat more than 200,000 in A&E, deliver over 8,000 babies and carry out more than 17 million tests.
Our size, scale and influence offer you unrivalled career opportunities and a forward-thinking approach to working that works around your lifestyle. From flexible hours and generous benefits to next level training, we make it easier to take your career to the top.
Job responsibilities
Please see attached job description for more information about this role and working at Royal Free London NHS Foundation Trust.
Person Specification
Experience
* Knowledge and experience with ATMP GMP QC (at least 2 years)
* Flow cytometry expertise
* FACSLyric experience to GMP level (1 year +)
Education & professional Qualifications
* MSc in relevant field
Skills and aptitudes
* Stability studies and GMP requirements
* Knowledge of writing QMS documents
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
£54,320 to £60,981 a year per annum inclusive of HCAS.
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