Job description

Principal Scientist, Bioassay Development & Testing

91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK

Principal Scientist, Bioassay Development & Testing

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

 

The role

To lead CMC bioassay development and testing activities within Immunocore. Line manage the Bioassay Development and Testing team, responsible for development and qualification of cellular potency and ELISA activity methods, technical transfer to external GMP manufacturers and oversight of validation. Responsible for contribution of relevant analytical data to regulatory submissions, ensuring their integrity and regulatory compliance. 

Key Responsibilities:

  • Lead development and qualification of bioassay (cellular potency and immuno-analytical) methods to support drug substance (DS) and drug product (DP) release and stability testing for the Immunocore therapeutic drug portfolio.
  • Oversee technical transfer of analytical assays to and validation of the assays at external CDMOs.
  • Manage a bioassay team of graduate scientists, who conduct studies in support of manufacturing operations and regulatory submissions.
  • Develop scientists of lower grades within the bioassay team.
  • Represent CMC within Immunocore Program teams, providing analytical strategic support and technical consultancy. Contribution is made through the evaluation, recommendation and implementation of best practice.
  • Contribute significantly to setting bioassay specifications and lead the generation of bioassay technical procedures, protocols and reports
  • Prepare reports and presentations of high quality suitable for internal and external audiences.
  • Lead bioassay experimental design and interpretation of results. Active participation in laboratory activities e.g. trouble shooting, problem solving and assistance at times of peak workload.
  • Contribute and manage the relevant bioassay data and information included within regulatory submissions (e.g. IND, IMPD, BLA, MAA).
  • Keep abreast of developments in area of expertise to advance company activities where deemed appropriate; providing in- depth analysis of new techniques and theories to advance the way the company works, raising and championing these with leaders and colleagues across the company.
  • Review competing priorities for projects and provide clear and thorough recommendations, considering the overall goals of the project, department and Company.
  • Implement safe working practices in laboratories for the team according to Immunocore EHS policies.

Experience & Knowledge:

  • Experience of various cellular, activity, plate based, flow-based and SPR bioassay methods in assay development, qualification and validation.
  • Established as an expert amongst peers in area of cellular, activity and immunoassays.
  • Experience with managing analytical activities at Contract Manufacturers.
  • Experience with early and late stage/commercial biopharmaceutical drug programs.
  • Presented detailed scientific findings to internal and external audiences.
  • Mentored and coached less experienced colleagues in scientific practices and theory.
  • Owned, participated and provided input to regulatory submission documentation and discussions.
  • Familiar with the principles of Good Manufacturing Practice (GMP).

Education & Qualifications

  • Essential: BSc. or MSc. in biochemistry, biological sciences, immunology or related discipline.
  • Desirable: PhD in related discipline.

Lead with Science and Discover What is Within:

  • We Value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Private medical and dental benefits.
  • 25 days Annual Leave and Bank Holidays
  • 4x Salary Life Insurance
  • 5% Pension Match
  • Income Protection
  • Parental Leave

 

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