Develop, qualify, and transfer complex ligand binding assays for measuring the PK of XTENylated molecules and relevant metabolites, and for detection of antibodies against XTENylated molecules.
Interact with CRO vendor partners to oversee PK and ADA method transfer, validation, and regulated sample analysis in support of GLP Tox and Clinical studies.
Perform Non-GLP pre-clinical sample analysis using in-house qualified assays (PK, PD, ADA).
Document all activities in an electronic notebook, compile data and analyze results in a timely fashion.
Present data in group settings to update other teams on progress of assay development.
Perform routine equipment maintenance, calibrations, and verifications as needed.
Work cross-functionally with members of other departments to complete tasks when required.
A minimum of a bachelor's degree in a scientific discipline with 5+ years of work experience, Master's degree with 3+ years or Ph.D. with 2+ years of work experience. Equivalent experience may be accepted.
Experience developing Ligand Binding Assays for PK and ADA is a must.
Proficient in working with Microsoft Word, Excel, and PowerPoint.
Ability to work in a fast-paced, dynamic environment with effective time-management skills.
Must be willing to work as part of a team and demonstrate good interpersonal skills.
Experience working in a GCP/GLP environment is desirable.
Mammalian cell culture experience is desirable.
Experience with electronic notebook systems, SoftMax Pro, and Prism a plus.