Research Associate - Assay Development

Research Associate - Assay Development

Join a cutting-edge biotechnology company advancing innovative diagnostic solutions for neurodegenerative diseases. We are seeking a highly motivated Research Associate - Assay Development to support the development, optimization, validation, and execution of analytical assays that drive research, product development, and scientific innovation.

This role offers the opportunity to take ownership of critical laboratory experiments, contribute to assay and process improvements, and work alongside cross-functional teams in a collaborative, science-driven environment. The ideal candidate brings strong assay development experience, hands-on laboratory expertise, and a passion for translating scientific discoveries into impactful diagnostic technologies.

Key Responsibilities

• Design, develop, optimize, and execute assays supporting research, analytical development, and product development initiatives.
• Perform routine and developmental laboratory assays with a focus on quality, reproducibility, and scientific rigor.
• Execute assay validation and qualification studies, including protocol execution, data review, and documentation.
• Evaluate assay performance and troubleshoot technical challenges to improve robustness, sensitivity, and reliability.
• Analyze experimental data, interpret results, and generate technical reports, presentations, and scientific summaries.
• Develop and maintain accurate laboratory records, notebooks, protocols, and supporting documentation.
• Follow and contribute to SOP development, revisions, and implementation while ensuring compliance with documentation and quality standards.
• Support investigations, deviations, CAPAs, and related quality system activities.
• Conduct protein characterization and protein aggregation analyses to support analytical and product development programs.
• Develop, optimize, and perform ELISA and other immunoassay-based methods.
• Collaborate with R&D, analytical, quality, and technical teams to advance project objectives and timelines.
• Present findings, share scientific insights, and contribute to continuous improvement initiatives across laboratory operations.
• Support audits, inspections, and regulatory documentation activities as needed.
• Manage multiple experiments and priorities effectively while maintaining high-quality laboratory execution.

Required Qualifications

• Bachelor's or Master's degree in Biology, Biochemistry, Molecular Biology, Bioengineering, Biotechnology, or a related scientific field.
• 4+ years of hands-on laboratory experience in biotechnology, diagnostics, pharmaceutical, or life sciences environments.
• Proven experience developing, optimizing, and executing analytical or biological assays.
• Hands-on experience performing assay validation, qualification, and transfer activities.
• Strong knowledge of regulated laboratory documentation practices, including: SOPs, Deviations, CAPAs, Investigations, Data integrity requirements.
• Demonstrated experience working in regulated laboratory environments.
• Strong experimental design, troubleshooting, and problem-solving skills.
• Experience evaluating and improving assay performance and robustness.
• Hands-on experience with: ELISA, Immunoassays, Protein characterization methods, Protein aggregation analysis.
• Proficiency in scientific data analysis and technical report generation.
• Excellent laboratory documentation and record-keeping skills.
• Strong communication and collaboration skills with cross-functional technical teams.
• Exceptional attention to detail and commitment to scientific excellence.

Preferred Qualifications

• Experience in assay development or analytical development within biotechnology, diagnostics, medical device, or pharmaceutical organizations.
• Knowledge of Good Documentation Practices (GDP), GMP-aligned systems, or quality management systems.
• Experience supporting regulated product development programs.
• Familiarity with design control, verification, validation, or regulatory submission activities.
• Experience driving assay, workflow, or process improvement initiatives.
• Strong presentation skills and ability to effectively communicate scientific findings.
• Proven ability to manage multiple projects and competing priorities in a fast-paced environment.
• Passion for advancing innovative diagnostic technologies and improving patient outcomes.

What Will Make You Stand Out

• Deep expertise in assay development and optimization.
• Strong analytical mindset with the ability to translate complex data into actionable insights.
• Experience working in highly regulated environments with quality-focused documentation practices.
• Ability to independently design experiments while thriving in a collaborative team setting.
• Enthusiasm for contributing to breakthrough diagnostic technologies and scientific innovation.

Work Environment

This is a fully onsite position located in San Diego, CA, within a modern biotechnology research and development laboratory. The environment is highly collaborative and innovation-focused, with significant hands-on bench work, frequent interaction with multidisciplinary teams, and opportunities to directly influence assay development and product advancement efforts.

The role follows a standard Monday-Friday schedule and offers exposure to cutting-edge technologies, regulated development processes, and meaningful scientific challenges that support the future of diagnostic medicine.