Sr. Scientist Immunoassay (ADA is a must have)

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. Senior Scientists are capable of working with minimal supervision. They will have sufficient technical understanding to develop or troubleshoot methods themselves and will be capable of demonstrating scientific leadership and decision making, directing the work of more junior staff. This may include managing projects or taking scientific lead, or supporting operational delivery within a team. Confidence in regular effective external communication may be expected. Senior Scientists will, where appropriate, be actively involved in training and mentoring of junior staff.Key responsibilities include;Build strong partnerships with our customers to help them progress their drug development pipelineStrong scientific decision making in accordance with the FDA regulatory guidancesHelp to design and deliver robust pre-clinical and clinical analytical methods within the ADA teamEnsure on time delivery of high quality methods to your customersAbility to adapt, be flexible and find solutions to our customers problemsThe ideal candidate will, or will have;Be able to lead and mentor scientists within your teamBe enthusiastic, proactive, and willing to suggest and implement process improvementsFocus on quality, and possess an excellent attention to detailCommunicate effectively; explaining the outcome of experiments to peers and customersa degree in biological science, or equivalent relevant experienceExperience in a GXP accredited laboratory is advantageousExpertise in the development and validation of immunogenicity assays on a variety of platforms, principally MSD but also Gyrolab.Awareness of M10 and FDA regulatory guidelinesHave good understanding of the statistics underlying cut point generationPractical experience with a variety of sample pretreatment strategies, including SPEAD and ACE.Familiarity with automation, use of the Hamilton is a plus.