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 PK, PD & 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 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.