Sr. Scientist, Immunoassay (PK, PD, ADA)

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.