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.
Skills, Education & Qualifications
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 a 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.
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