Sr. Research Associate, CLIA Lab Immunology

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

65d

About The Position

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 successful candidate will work closely with cross-functional teams to ensure that assays meet regulatory standards and contribute to the advancement of gene therapy projects. The ideal candidate will have a strong background in molecular biology, cell culture, and aseptic techniques. This 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 (Good Clinical Laboratory Practices) laboratories, GLP (Good Laboratory Practices), CLIA (Clinical Laboratory Improvement Act), 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.

Requirements

Bachelor's degree in biological sciences, medical technology or related field with 5+ years of experience working in a high-complexity CLIA laboratory OR Master’s degree in biological sciences, medical technology or related field with 2+ years’ experience working in a high-complexity CLIA laboratory
Expertise with immunoassay techniques such as ELISA and cell-based assays
Experience designing, validating, and implementing new assays
Proficient in the operation and maintenance of immunoassay plate readers
Comprehensive understanding of CLIA, FDA, and other applicable regulations
Experience reviewing and evaluating quality control data and implementing corrective actions

Nice To Haves

Total antibody assay, Cell based neutralizing antibody assay, MSD assay platform
Knowledge about CLSI guidelines

Responsibilities

Assay Development 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
Implementing CLSI guidelines for assay development as needed
Optimize and troubleshoot experimental protocols to ensure accuracy, reproducibility, and efficiency
Assay Validation Preparation of validation plans in accordance with SOPs.
Validate assays according to regulatory guidelines (e.g., FDA, ICH) and industry standards
Preparation of validation reports in close collaboration with QA team.
Collaborate with cross-functional teams to ensure assay alignment with program goals
Data Analysis and Reporting Analyze and interpret data including 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 assay-related data provided by the CRO and derive meaningful conclusions
Laboratory Operations Responsible for day-to-day operations and management of a clinical laboratory, ensuring that all procedures adhere to the standards set by the Clinical Laboratory Improvement Amendments (CLIA)
Manages the laboratory's inventory of equipment, reagents, and supplies. This includes coordinating maintenance, troubleshooting, calibration, and repair to ensure all instruments function correctly
Ensures the laboratory participates in and complies with an approved proficiency testing program. Review the results and ensure corrective action is taken for any unacceptable findings
Regulatory and Administrative Maintains thorough and accurate records for all laboratory activities, including quality control, maintenance, training, and corrective actions
Assists the lab director in preparing for inspections and internal or external audits from regulatory authorities
Upholds all federal, state, and local regulations and safety protocols, including CLIA and safety standards from agencies
Collaboration and Communication Stay current with the latest advancements in gene therapy research and apply this knowledge to your work.
Collaborate with colleagues to achieve project goals and timelines
Communicate effectively with team members, management, and external partners