Sr. Research Associate, CLIA Lab Immunology

Sr. Research Associate, CLIA Lab Immunology

Ask Bio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease.

Ask Bio’s gene therapy platform includes Pro
10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters.

Our Vision: Pioneering science to create transformative molecular medicines.

Our Mission: Lead innovative science and drive clinical outcomes to transform people's lives.

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

We are seeking a highly motivated and detail-oriented Senior Research Associate to join our Bioanalytical Group. The successful candidate will play a key role in developing and validating binding antibody and neutralizing antibody assays performed on preclinical and clinical samples to support our gene therapy programs. This position requires hands-on experience in immune assay techniques and a basic understanding of gene therapy research.

The candidate will work closely with cross-functional teams to ensure assays meet regulatory standards and contribute to the advancement of gene therapy projects. A strong background in molecular biology, cell culture, and aseptic techniques is essential. The position offers an opportunity to work in a dynamic, fast-paced environment and contribute to the development of innovative gene therapies for patients in need.

Antibody assay development, qualification and validation activities will be performed in compliance with GCLP, GLP, CLIA, and national, international, and state regulations. The Senior Research Associate, Clinical Immunology will be based in RTP, NC and will report to the Associate Director, Clinical Immunology.

• Develop, optimize, and validate immunoassays using various platforms (e.g., ELISA, MSD, flow cytometry, cell-based).
• Design and execute experiments to evaluate assay performance to meet FDA and CLIA guidelines.
• Implement CLSI guidelines for assay development as needed.
• Optimize and troubleshoot experimental protocols to ensure accuracy, reproducibility, and efficiency.

• Prepare validation plans in accordance with SOPs.
• Validate assays according to regulatory guidelines (e.g., FDA, ICH) and industry standards.
• Prepare validation reports in close collaboration with QA team.
• Collaborate with cross-functional teams 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.
• Perform in-depth data analysis using advanced statistical and bioinformatics tools and draw meaningful conclusions from the results.
• Evaluate…