Sr. Scientist Immunoassay

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 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

The ideal candidate will, or will have;

• 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.