Job Title: Sr. Research Associate II

Work Location: Marin County, California

Summary:

This position focuses on bioanalytical and biomarker method development to support translational research and both non-clinical and clinical development programs. The role involves developing, transferring, and validating methods for quantifying biotherapeutic proteins, biomarkers, and anti-drug antibodies, contributing to the characterization of immunogenicity, pharmacokinetics, and biological activities throughout all phases of drug development.

Responsibilities:

• Develop and optimize bioanalytical assays to support pharmacokinetic, immunogenicity, and biomarker analysis for biotherapeutic programs.
• Design and execute ligand-binding, hybrid, and cell-based assays for non-clinical and early clinical research.
• Facilitate technology transfer of assays to internal teams and external research organizations.
• Contribute to method qualification, validation, and sample analysis in accordance with regulatory standards.
• Analyze and interpret data from various assay platforms, compiling results for multiple studies.
• Present findings through reports, presentations, and discussions with stakeholders.
• Assist in authoring and reviewing technical documents, including analysis plans, development reports, and study protocols.
• Prioritize and manage multiple projects, troubleshoot technical issues, and implement new analytical technologies to enhance assay capabilities.

Qualifications:

• Master’s degree in Chemistry, Biochemistry, Biology, Immunology, or related field with 4-6 years of relevant experience, or Bachelor’s degree with 6-8 years of related experience.
• Experience developing and qualifying ADA, PK, NAb, and biomarker assays.
• Proficiency in protein techniques such as Western blot, ELISA, multiplexing platforms (e.g., MSD/Luminex), protein expression, PCR, and antibody development/characterization.
• Demonstrated independence in laboratory work and ability to collaborate on projects.
• Experience with data management systems and familiarity with data/statistical analysis software.
• Strong organizational and time management skills, with the ability to multitask and manage diverse projects in a fast-paced environment.
• Familiarity with regulatory and industry guidance, including GLP bioanalytical assay requirements.

Published Category: Analytical & Process Development