AskBio Inc. is looking for a Senior Research Associate, Clinical Immunology to join our Bioanalytical Group at our Research Triangle Park site. You will play a key role in developing and validating binding and neutralizing antibody assays performed on preclinical and clinical samples to support our gene therapy programs. This position offers an opportunity to work in a dynamic, fast-paced environment and contribute to the development of innovative gene therapies.
What You'll Do
- Develop, optimize, and validate total antibody and neutralizing antibody assays using platforms like ELISA, MSD, flow cytometry, and cell-based systems.
- Design and execute experiments to evaluate assay performance to meet FDA and CLIA guidelines.
- Implement CLSI guidelines for assay development and troubleshoot experimental protocols.
- Prepare validation plans and reports in accordance with SOPs and regulatory guidelines.
- Collaborate with cross-functional teams and the QA team to ensure assay alignment with program goals.
- Analyze and interpret data from assay development and validation studies.
- Prepare and present data to project teams, management, and regulatory agencies.
- Perform clinical sample analysis and prepare comprehensive reports for clinical sites.
- Conduct in-depth data analysis using advanced statistical and bioinformatics tools.
- Evaluate assay-related data from CROs and derive meaningful conclusions.
- Maintain a safe, organized lab and develop SOPs for consistent research quality.
- Stay current with the latest advancements in gene therapy research.
- Collaborate effectively to achieve project goals and timelines.
What We're Looking For
- A Bachelor’s degree in a relevant field with 5 years of work experience, a Master’s with 2 years, or 9 years of relevant experience.
- Minimum of one year of experience in troubleshooting assays.
- Minimum of one year of experience in project management.
- Previous experience with antibody assays, particularly MSD-based assays, neutralizing antibody assays, and ELISA.
- Experience working in a regulated laboratory environment (GxP).
- Knowledge of industry best practices and regulatory requirements, including GCLP, GLP, GCP, CLIA, Good Documentation Practice, and 21 CFR Part 11.
- Strong collaborative skills to work cross-functionally in a matrixed team.
- Ability to handle multiple projects and teams simultaneously.
Nice to Have
- Ability to work independently in a fast-paced, highly interactive environment.
- Excellent verbal and written communication skills.
- Prior experience with instrument maintenance and management.
- Hands-on experience in immunoassay technology, including ELISPOT.
- Ability to build open, collaborative relationships within a multi-disciplinary team.
- Experience with LIMS systems, especially LabVantage.
Technical Stack
- ELISA
- MSD (Mesoscale Discovery)
- Flow cytometry
- Cell-based assays
- ELISPOT
- LIMS (LabVantage)
Team & Environment
You will join the Bioanalytical Group within the Clinical Immunology functional group, reporting to an Associate Director. You will be part of a collaborative team working on critical assays for gene therapy development.
Work Mode
This is an onsite position based at our Research Triangle Park, North Carolina location.
AskBio Inc. is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws.
