Immunogenicity and Assay Development Specialist

2 months ago


Fordham, Essex, United Kingdom Resolian UK Full time
About the Role

We are seeking a highly skilled and experienced Scientific Leadership and Innovation Manager to join our team at Resolian UK. As a key member of our immunogenicity group, you will be responsible for providing scientific leadership and oversight of development and validation within our immunoassay department.

Key Responsibilities
  • Strategic Partnership Development: Build strong partnerships with our customers to help them progress their drug development pipeline.
  • Scientific Decision Making: Make strong scientific decisions in accordance with FDA regulatory guidelines.
  • Method Development and Delivery: Help design and deliver robust pre-clinical and clinical analytical methods within the ADA team.
  • Quality and Timeliness: Ensure on-time delivery of high-quality methods to our customers.
  • Problem-Solving and Adaptability: Adapt, be flexible, and find solutions to our customers' problems.
Requirements
  • Leadership and Mentoring: Lead and mentor scientists within your team.
  • Process Improvement: Be enthusiastic, proactive, and willing to suggest and implement process improvements.
  • Quality Focus: Focus on quality and possess an excellent attention to detail.
  • Communication: Communicate effectively, explaining the outcome of experiments to peers and customers.
  • Education and Experience: Hold a degree in biological science or equivalent relevant experience.
  • Desirable Skills: Experience in a GXP accredited laboratory, expertise in the development and validation of immunogenicity assays, awareness of M10 and FDA regulatory guidelines, and good understanding of the statistics underlying cut point generation.


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