Senior Analytical Development Scientist – Team Lead – Full Time – London

  • Permanent
  • London
  • Country: United Kingdom
  • Address Region: London
  • Salary: £40000 - £50000/annum + Package

Medical/Pharmaceutical/Scientific

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.

Key Responsibilities:

* 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.

Essential Experience:

* 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

Desirable Experience

* 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

Location: London

To apply for this job please visit www.cv-library.co.uk.

Related Jobs
  • Engineering
    Permanent
    London

    Foot Mobile Engineer A new M&E Engineer to work as a Foot Mobile Engineer is needed for one of our leading FM / Building Services business. This Multi Skilled Foot Mobile Engineer will be expected
  • Engineering
    Permanent
    Walsall

    Quality & Process Improvement Engineer (Presswork/Fabrication/Assembly) c£25,000 + excellent benefits Our client, a long-established manufacturer & supplier of pressed & assembled com
  • IT
    Permanent
    Swindon, Wiltshire

    Role: Software Developer - Java Salary: £40-55K Location: Remote Currently A very well-known and widely-respected research research council are looking to expand their team at the Swindon office.