Responsibilities
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Build strong partnerships with our customers to help them progress their drug development pipeline
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Strong scientific decision making in accordance with the FDA regulatory guidances
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Help to design and deliver robust pre-clinical and clinical analytical methods within the PK, PD & ADA team
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Ensure on time delivery of high quality methods to your customers
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Ability to adapt, be flexible and find solutions to our customers problems
Skills, Education & Qualifications
- Be able to lead and mentor scientists within your team
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Be enthusiastic, proactive, and willing to suggest and implement process improvements
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Focus on quality, and possess an excellent attention to detail
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Communicate effectively; explaining the outcome of experiments to peers and customers
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a degree in biological science, or equivalent relevant experience
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Experience in a GXP accredited laboratory is advantageous
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Expertise in the development and validation of immunogenicity assays on a variety of platforms, principally MSD but also Gyrolab.
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Awareness of M10 and FDA regulatory guidelines
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Have good understanding of the statistics underlying cut point generation
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Practical experience with a variety of sample pretreatment strategies, including SPEAD and ACE.
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Familiarity with automation, use of the Hamilton is a plus.
UK-Senior Scientist Immunoassay (PK, PD, ADA)
