My Client, a fast growing and exciting T Cell therapy company is currently looking to add a Analytical Development Scientist – Team Leader to their expanding Analystical Development and 1Quality Control teams.
* Contribute to the design and implementation of experimental strategies to support the development and manufacture-readiness of a growing regulatory T cell therapy pipeline.
* This role will involve project leadership and will also include opportunities to be part of Project teams responsible for building non-clinical and CMC strategies to support regulatory submissions for Phase I clinical trials in T cell Therapy.
* Collaborate with other team members and lead the development of analytical methods suitable for the analysis of high-quality cell-based therapeutic products.
* Lead the evaluation of test methods as fit for purpose for transfer to the QC environment.
* Document analytical method development activities in laboratory notebooks and co-author analytical method development reports to support regulatory documentation.
* Lead analytical method transfer activities to the Quality Control group.
* Work with external service providers.
* Any other duties as required (following consultation).
* The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company.
* Experience from a directly relevant biotechnology or pharmaceutical industry
* Degree or higher degree in Biology/Biomedical Science/Immunology or related discipline
* Minimum of 5 years’ experience in an Assay Development Role
* Extensive experience developing, implementing, and evaluating assays as fit for purpose (ICH) for the analysis and characterisation of cell-based therapies
* Understanding of critical process parameters (CPP), critical quality attributes (CQA), comparability etc. relating to manufacturing process
* Skills/Specialist knowledge Experience with a range of biopharmaceutical and cell-based techniques including some or all of: Aseptic technique, Sterility testing, Cell Counting, Flow cytometry, PCR (ddPCR, dPCR, qPCR), Mammalian cell culture, Potency testing
* Good understanding of cell biology and immunology
* Strong verbal and written communication skills
* Flexible, self-motivated and focused on team outcomes
* Understanding of and familiarity with GMP regulations
* Excellent organisational skills with the ability to present results clearly and logically, working co-operatively as part of a team as well as independently
* Excellent attention to detail and ability to accurately follow SOPs
* Ability to identify and implement solutions
* Commitment to high quality work
* Experience of working in a busy laboratory environment
* Experience of training, mentoring and supervision of junior laboratory staff
For more information please
Salary: £40000 – £50000/annum + Package
Job Type: Permanent
To apply for this job please visit www.cv-library.co.uk.