GMP Production/QC Scientist (Stem Cells)

Job description

Background

The Ocular Cell and Gene Therapy group, based in KCL’s Centre of Gene Therapy and Regenerative Medicine, develops a wide variety of novel cell and gene therapies for the treatment of neurodegenerative diseases, with a particular emphasis on retinal disease.

This is an exciting opportunity to work at the interface of basic and clinical research in a group that is at the forefront of translating ocular research into clinical application. Led by Professors Robin Ali and Rachael Pearson (previously at UCL’s Institute of Ophthalmology), it is one of the largest cellular and gene therapy groups in the country. Over the past 20 years, the group has led first-in-human clinical trials of gene and cell therapy for eye disease, and we are now in the pre-clinical development phase for clinical trials for photoreceptor cell therapy.  

Role Purpose

The post holder will  

•         Work with the pre-clinical team to support the product development, manufacturing and QC testing of GMP grade stem cell-derived ATMPs.  

•         Play an active role in aseptic cell manufacturing processes and acquiring and analysing QC data.  

•         Assist with quality and document control plus other activities related to maintaining compliance with GMP.  

We are looking for a highly motivated individual who has a demonstrable interest in working with stem cells and developing GMP-compliant manufacturing protocols. This is a unique opportunity to work in a vibrant, collaborative translational research environment with very high potential to learn new skills. 

This post will be offered on a fixed-term contract for 24 months in the first instance. 

This is a full-time post – 100% full time equivalent

Key responsibilities

Provide a range of technical and administrative support to pre-clinical development staff, working within established standards and protocols, to ensure the smooth running of daily activities and GMP compliance, where appropriate.

This includes:

•         Perform ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards.

•         Performing routine aseptic maintenance and differentiation of pluripotent stem cells and contribute to the stem cell maintenance rota, which involves non-core hours working.

•         Performing QC testing for starting materials, in-process and product testing, including molecular and cellular biology techniques, including preparation of samples for flow cytometry.

•         Analyse, interpret, validate, and report the results of routine investigations, working at the level of responsibility and conduct required of an Junior Scientist.

•         Undertaking reagent preparation and management of QC materials (media preparation, aliquoting, stock management)

•         Supporting facility staff in ensuring compliance of clean room preparation and quarantine procedures.

•         Following local procedures and comply with quality risk management principles in all aspects to ensure product quality, patient safety and GMP compliance.

•         Laboratory housekeeping – maintenance of laboratory space, including equipment, in GMP compliant state.

•         Performing data entry, collation and analysis.

•         Engaging in Continuing Professional Development and training initiatives. Undergo training and follow instructions related to house-keeping procedures and GMP compliance activities.

•         Providing administrative support, including preparing and managing GMP documentation (e.g. logbooks, worksheets, documentation trackers, forms).

•         Communicate information in a clear and precise way, both orally and in writing.

•         Timely completion of own workload.

•         Implementing local environmentally sustainable practices, following the King’s sustainability audit process, where appropriate.

•         Forge relationships with colleagues in the School, Faculty, university and external to the university, to build relationships, disseminate and get information, coordinate, and deliver the service.

•         Facilitate an inclusive culture and ethos working with academic, research and other professional services staff and colleagues external to King’s.

•         Actively engage in King’s Technical Network, building a network across the Faculty to provide peer support and opportunities to share best practice.

•         Participate in cross-School/ Faculty/ university projects and initiatives for up to 10% FTE.

Skills, knowledge, and experience

Essential criteria

Qualifications and Training

1.       Minimum level 3 qualification, e.g. A levels, AS levels, International Baccalaureate diploma or other Level 3 qualification, plus work experience in relevant technical/scientific posts OR Considerable knowledge and skills gained through work experience in relevant technical or scientific posts.

2.       Evidence of an active commitment to career development within life sciences, such as professional registration with relevant organizations, undergoing practical, on the job training within a life sciences laboratory &/or clear progression in increasingly demanding jobs.

Skills / Experience

3.       Experience of working in a life sciences laboratory with demonstrable skills in molecular and cellular biology and an ability to apply learnt techniques to the work context.

4.       Skilled in aseptic cell culture techniques and working to best practice in clean room environment.

5.       Experience in providing administrative support and maintaining accurate and detailed records.

Knowledge

6.       Good understanding of bioprocessing, GMP manufacturing &/or cell-cased therapy.

Competencies

7.       Ability to precisely and reliably follow instructions and procedures.

8.       Excellent record keeping and attention to detail.

9.       Competence in managing and handling electronic & paper-based documentation.

10.   Clear spoken and written communication skills and good interpersonal skills.

11.   Competence in working according to local Health & Safety policies and environmental sustainability.

12.   Commitment to working as a team member towards the overarching objectives of the programme and willingness to provide support beyond core hours, as required.

Desirable criteria

1.       Experience of working to GMP laboratory standards.

2.       Experience of working with electronic quality documentation and batch records and working with QC and quality assurance staff.

3.       Hands on experience of working with human pluripotent stem cell cultures.

4.       Experience of flow cytometry/cell sorting techniques or other relevant methods