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Scientific Leadership Role

2 months ago

Fordham, Essex, United Kingdom Resolian UK Full time
Scientific Leadership and Regulatory Compliance

The focus of this role is scientific leadership and oversight of development and validation within our immunogenicity group, within the wider immunoassay department. You will be responsible for helping us to deliver high quality ADA method and sample analysis results to our customers in compliance with GLP/GCP.

Key Responsibilities:

  • Build strong partnerships with our customers to help them progress their drug development pipeline
  • Strong scientific decision making in accordance with the FDA regulatory guidances
  • Help to design and deliver robust pre-clinical and clinical analytical methods within the ADA team
  • Ensure on time delivery of high quality methods to your customers
  • Ability to adapt, be flexible and find solutions to our customers problems

Requirements:

  • Be able to lead and mentor scientists within your team
  • Be enthusiastic, proactive, and willing to suggest and implement process improvements
  • Focus on quality, and possess an excellent attention to detail
  • Communicate effectively; explaining the outcome of experiments to peers and customers
  • a degree in biological science, or equivalent relevant experience
  • Experience in a GXP accredited laboratory is advantageous
  • Expertise in the development and validation of immunogenicity assays on a variety of platforms, principally MSD but also Gyrolab.
  • Awareness of M10 and FDA regulatory guidelines
  • Have good understanding of the statistics underlying cut point generation
  • Practical experience with a variety of sample pretreatment strategies, including SPEAD and ACE.
  • Familiarity with automation, use of the Hamilton is a plus.