Scientist / Senior Scientist, Bioanalysis - Ligand Binding Assays

About This Role

This role involves developing and optimizing ligand binding assays to support preclinical non-regulated PK studies for biologics drug development programs. The scientist will perform bioanalysis of samples, ensuring data quality and integrity, and collaborate with various teams within a neuroscience-focused biopharmaceutical company.

Responsibilities

• Develop, optimize, and qualify ligand binding assays (e.g., ELISA, MSD/ECL, Gyrolab) to support preclinical non-regulated PK studies of antibodies, bispecifics, and fusion proteins in rodents and monkeys
• Perform hands-on bioanalysis of preclinical samples and ensure data quality, integrity, and scientific rigor
• Author and review bioanalytical protocols, assay qualification/validation reports, and preclinical study reports
• Analyze, interpret, and clearly communicate PK bioanalytical data to project and DMPK teams
• Collaborate closely with DMPK, toxicology, and pharmacology groups to support study design and data interpretation
• Interact with external CROs, including supporting assay and method transfer, providing technical oversight, and reviewing data/reports
• Troubleshoot assay issues and continuously improve assay performance and workflows
• Perform ADA assay development and support (screening/confirmatory/titer) on selected programs
• Provide technical leadership, mentor junior scientists, and contribute to preclinical bioanalytical and outsourcing strategy (Senior Scientist level)

Requirements

• Hands-on experience with ligand binding assay development for PK bioanalysis
• Experience supporting preclinical non-regulated studies, preferably in rodents and/or non-human primates
• Basic understanding of GLP principles and bioanalytical best practices
• Strong experimental, data analysis, and documentation skills

Qualifications

• BS/BA, MS/MA, or PhD in a relevant scientific field
• 2+ years of industry experience in bioanalysis with a BS/BA degree, or some experience with MS/MA or PhD.

Nice to Have

• Experience with ADA assay development
• Demonstrated expertise in preclinical PK LBA strategy and execution (for Senior Scientist level)
• Experience supporting GLP toxicology studies and working with quality/compliance functions (for Senior Scientist level)
• Proven experience interacting with and overseeing external CROs (for Senior Scientist level)

Skills

* Required skills

Benefits