Research Associate III

The Research Associate III is responsible for developing and performing Ligand Binding Assays (e.g. ELISAs, ECLAs) for pharmacokinetic (PK) and toxicokinetic (TK) assessments to advance research, pre-clinical, and clinical stage programs. Collaborates with others to ensure timely analysis of samples and to discuss assay development issues and techniques.

Responsibilities:

• Analyze clinical samples in compliance with GCP regulations and Nektar’s SOPs.
• With guidance, develop complex assays for measuring the PK/TK of Nektar’s PEGylated-protein, drug candidates.
• Contribute to the troubleshooting of newly developed and established test methods.
• Compile data and analyze results in terms of quality/validity.
• Document all activities in the electronic notebook (eLN) and Laboratory Information Management System (LIMS).
• Perform routine equipment maintenance, calibrations, and verifications as per SOP.
• Collaborate with other bioanalytical team members to complete tasks and meet departmental goals.
• Generate various technical documents (e.g. Method Development Reports, Study Plans, Test Methods, Validation Reports).

Requirements:

Requires a Bachelor’s degree in biology, biochemistry, or other related scientific discipline with a minimum of 5 years work experience in a research and/or development environment. Equivalent experience may be accepted.

• In depth technical knowledge to understand the caveats of Ligand Binding Assays and to recognize issues during development and validation.
• Working knowledge of FDA, EMA, and ICH validation guidances.
• Experience performing and developing Ligand Binding Assays for PK/TK is required.
• Experience working in a GCP/GLP environment is desirable.
• Ability to work on multiple task/projects at the same time.
• Ability to work in a fast-paced, goal-oriented environment.
• Effective time-management skills.
• Self-motivated to carry out both new and routine tasks.
• Must be willing to work as part of a team and demonstrate good interpersonal skills.
• Past experience working with Meso-Scale Discovery (MSD) imager and software a plus
• Proficient working with Microsoft Word, Excel, and PowerPoint.
• Past experience with electronic notebook and/ or LIMS a plus.