Reference
ANDEVTEAM
Type
Permanent
Location
London
Salary
£35,000-£70,000
Category
Research & Development
Sector
Pharmaceuticals / Biotechnology / FMCG

ABOUT AVAILABLE POSITIONS

Northreach are partnering with an exciting biotech company specialising in developing of engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system.

Their mission is to bring transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.

KEY RESPONSIBILITIES - ANALYTICAL DEVELOPMENT TEAM

ANALYTICAL DEVELOPMENT TEAM

 

We are looking for a talented and highly motivated individual with experience of Analytical Development in the cell therapy setting. He/she should also have significant understanding of the regulatory aspects for developing and evaluating assays principally, flow cytometry assays, for transfer to a QC laboratory environment for Ph1/2 clinical manufacture.

 

MAIN RESPONSIBILITIES

  • Collaborate with other team members and contribute to the development of analytical methods suitable for the analysis of high-quality cell-based therapeutic products.
  • Lead assigned objectives using the resource of the team.
  • Lead the development and optimisation of analytical methods suitable for the testing of cell-based products.
  • Lead the evaluation of test methods as fit for purpose for transfer to the QC environment.
  • Ability to manage multiple projects simultaneously and cross-functionally.
  • Plan and coordinates activities of reports to meet agreed timelines.
  • Document analytical method development activities in laboratory notebooks and author analytical method development reports to support regulatory documentation.
  • Lead analytical method transfer activities to the Quality Control group.
  • Manage external service providers and identify new collaborations.
  • Maintain a high-level of professional expertise through familiarity with scientific literature and best industry practices.
  • Manages activities of technicians, research associates and scientist Level II/II (50% of time) directing the work of others.
  • Lead in presenting and defending data in working teams and at lab meetings.
  • Act as an expert / consultant and scientific resource for others in the department
  • 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

THE IDEAL CANDIDATES

  • Experience from a directly relevant biotechnology or pharmaceutical industry (E)
  • Experience of working in a busy laboratory environment (E)
  • Ph.D or MD/ Ph.D in relevant scientific discipline with +5 years academic or industry related experience (E)
  • Minimum of 3 years’ experience in an Assay Development Role (E)
  • Significant experience developing, implementing, and evaluating assays as fit for purpose (ICH) for the analysis and characterisation of cell-based therapies (E).
  • Understanding of critical process parameters (CPP), critical quality attributes (CQA), comparability etc. relating to manufacturing process (E).
  • Skills/Specialist knowledge and/or 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 (E)
  • Experience of panel design for multiparameter flow cytometry (Aurora, Lyric) including the testing, implementation of appropriate gating strategies, implementation of controls and regulatory compliant fit for purpose assay assessment prior to transfer to Quality control. (P)
  • Good understanding of cell biology and immunology (E)
  • Excellent Problem-Solving Skills (E)
  • Ability to interpret complex data and implement new work methods (E)
  • Strong verbal and written communication skills (E)
  • Flexible, self-motivated, and focused on team outcomes (E)
  • Understanding of GMP regulations as applied to Assay Development / evaluation (E)
  • Excellent organisational skills with the ability to present results clearly and logically, working co-operatively as part of a team, as well as independently (E)
  • Excellent attention to detail and ability to accurately follow SOPs (E)
  • Commitment to high quality work (E)
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