Scientist for Assay Development

6 days ago

York, York City, United Kingdom HAR Labcorp Early Development Laboratories Limited Full time
About the Role

We are seeking a highly skilled Scientist for Assay Development to join our team at HAR Labcorp Early Development Laboratories Limited. As an Assay Development Scientist, you will play a pivotal role in developing and optimizing cell-based potency assays to support projects in all phases of the drug development pipeline.

Main Responsibilities
  • Deliver expertise in cellular potency assay development and optimization for the purpose of implementation in the quality control of drug development projects.
  • Implement new technologies and current scientific thinking in the field of cellular potency assay development while working in partnership with colleagues in the assay development team to ensure that assays are robust and fit for purpose.
  • Implement projects to agreed timelines such that the objectives of the project are met, including delivery of more than one agreed area of work in parallel where appropriate.
  • Contribute novel ideas and use judgment and knowledge where appropriate to influence the work of the project.
  • Maintain an awareness of current developments in the literature, regulations, and scientific community.
  • Achieve personal scientific visibility through project contributions and internal presentations at departmental or functional meetings.
  • Maintain accurate and reliable record keeping and have a meticulous approach to the analysis and interpretation of assay data.
  • Train individuals in correct cellular potency assay execution.
  • Act as the subject matter expert during troubleshooting and analytical investigation scenarios both with internal colleagues and external clients.
  • Contribute to the continuous improvement process by identifying opportunities in the workplace where improvements can be made.
Requirements
  • A BSc degree in a relevant scientific discipline (e.g. Biochemistry, Biomedical Sciences, Biology) plus relevant postgraduate experience in cellular potency assay design and development, achieved in the pharmaceutical or biotechnology industry or as part of an MSc or PhD program.
  • Extensive experience in the handling and maintenance of mammalian cell cultures.
  • Experience in 96-well plate cell-based bioassays (e.g. cytotoxicity, proliferation, ADCC), ELISA or AlphaLisa.
  • A practical understanding of a wide range of cellular assay methods and technologies (for example fluorescence, luminescence, flow cytometry, TRF) as applied to a range of biological drug targets.
  • Knowledge of GMP regulatory requirements relating to analytical testing and data integrity.
  • Excellent problem-solving skills, strong delivery focus, and communication skills.
  • Be able to work both independently and within a project team.
Desirable Requirements
  • A PhD in a relevant scientific discipline.
  • Experience in cell bank production.
  • Experience in the automation of plate-based bioassays.
  • Experience in the development of cellular assays for gene and cell therapy products.
  • Knowledge and application of 'design of experiment' in assay design and development.
  • Experience in the use of bioanalytical software (e.g. SoftMax Pro, PLA, QuBAS etc.).
  • Excellent team working and networking skills with experience of interacting effectively across different disciplines and expertise.
  • Experience of working in external collaborations both in academia and pharmaceutical industry.

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