Scientist / Senior Scientist – Bioanalytical Immunogenicity (ADA/NAb Assay Development)
Location: San Diego, CA | Full-Time

WHO WE ARE

BioLegacy, part of the PharmaLegacy family, is a leading preclinical contract research organization (CRO) dedicated to delivering high-quality, GLP-compliant research services to support drug development. Our team of passionate scientists partners with clients across the globe to provide innovative solutions in bioanalysis, immunology, oncology, and more. We are committed to scientific excellence, regulatory integrity, and helping our partners bring life-changing therapies to patients faster.

ABOUT THE ROLE

We are seeking a Scientist or Senior Scientist to join our Bioanalytical team, specializing in the development and validation of Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) assays for preclinical GLP studies.
In this bench-focused role, you will design, optimize, and implement cutting-edge bioanalytical methods—leveraging platforms such as ELISA, MSD, Luminex, and cell-based assays—to evaluate immunogenicity in support of drug development programs.
Please note: This role does not involve analysis of clinical samples.

KEY RESPONSIBILITIES

• Develop & Validate Immunogenicity Assays Design, optimize, and validate ADA and NAb ligand binding assays (ELISA, MSD), cellbased assays, and flow cytometrybased methods for preclinical studies.
• Ensure Regulatory Compliance Conduct method validation in accordance with FDA, ICH, and EMA guidelines in GLP and nonGLP environments.
• Analyze & Report Data Interpret bioanalytical results, prepare technical reports, and present findings to crossfunctional teams; link immunogenicity data to PK/PD outcomes.
• Collaborate Across Functions Partner with internal teams and CROs to ensure scientific rigor, regulatory compliance, and timely project delivery.
• Drive Innovation Implement process improvements, evaluate emerging technologies, and support automation initiatives to enhance assay quality and throughput.
  Qualifications