Associate III, Analytical Development and Quality Control, Potency Assays

Role Summary

We are seeking a Research Associate to support Quality Control testing of potency assays for an Antibody Drug Conjugate (ADC) portfolio. The primary responsibility is to execute routine QC potency testing in support of release and stability programs. The role also supports assay development, optimization, qualification, and characterization testing for binding ELISA and cell-based cytotoxicity assays. The ideal candidate has hands-on experience with ADC cell-based potency assays and can work in a GMP-regulated environment. Occasional evening or weekend work may be required to support testing timelines.

Responsibilities

• Perform routine QC potency testing for ADC products, including execution of binding ELISA and cell-based cytotoxicity assays in support of release and stability testing.
• In collaboration with Contract Testing Labs (CTLs), develop robust potency methodologies to support ADC functional characterization, release and stability testing.
• Support assay development, optimization, and troubleshooting for binding ELISA and cytotoxicity assays under the guidance of senior staff.
• Assist with assay qualification, method transfer, and comparability activities, including data analysis and report preparation.
• Maintain laboratory readiness by following SOPs, managing reagents, maintaining equipment, and supporting general lab organization.
• Participate in the preparation and revision of SOPs, protocols, and technical reports to support QC and analytical development activities.
• Collaborate closely with cross-functional teams, including Analytical Development, Research, Quality Assurance, and external partners, to support project timelines and objectives.
• Contribute to continuous improvement efforts by identifying opportunities to enhance assay robustness, efficiency, and data quality.

Qualifications

• A bachelor’s degree in Molecular and Cellular Biology, Biochemistry, or a related field.
• A minimum of 5 years of relevant industry laboratory experience with at least 3 years of potency assay development and quality control testing.
• Hands on experience performing ELISA and/or cell-based assays; experience with cytotoxicity assays is plus.
• Familiarity with GMP, GLP, or regulated laboratory environments is preferred.

Skills

• Practical understanding of mechanism of action assay principles, including ligand-binding assays and cell-based functional assays.
• Experience with common laboratory techniques such as pipetting, cell culture, reagent preparation, and plate-based assays.
• Ability to analyze, interpret, and clearly present experimental data using standard software tools.
• Strong attention to detail and commitment to data integrity and documentation accuracy.
• Ability to follow established procedures while also contributing to assay optimization efforts.
• Effective communication skills and the ability to work collaboratively in a team-oriented environment.
• Strong organizational and time-management skills with the ability to manage multiple tasks in a fast-paced setting.