Senior Scientist Immunoassay (PK, PD, ADA)

The focus of the Senior Scientist (IA) is oversight and management of development, validation and sample analysis projects within Immunoassay. You'll be responsible for delivering high quality to results to our customers in compliance with GLP/ GCP. 

 What will you be doing?

• Building strong partnerships with our customers to help them progress their drug development pipeline
• Making strong scientific decisions in accordance with the FDA regulatory guidances
• Helping to design and deliver robust pre-clinical and clinical analytical methods within the PK, PD & ADA team
• Ensuring the on time delivery of high quality methods to your customers

Who we're looking for

We are looking for someone with the ability to adapt, be flexible and ultimately, find the best solutions to our customer's problems. This role is a key part in leading and mentoring scientists within the IA team, so if you're enthusiastic, proactive in your approach, and are willing to suggest and implement process improvements, you'll be a great fit.

You'll also have: 

• Excellent attention to detail 
• Effective communication skills; clearly explaining the outcome of experiments to peers and customers
• A degree in biological science, or equivalent relevant experience
• 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.

Experience in a GXP accredited laboratory is advantageous as well as familiarity with automation and the use of the Hamilton.