Sr. Research Associate, CLIA Lab Immunology

reputed company., a wholly owned and independently operated subsidiary of reputed company AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. reputed company maintains a portfolio of clinical programs across a reputed company 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. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive reputed company of capsids and promoters. With global reputed company in Research Triangle Park, reputed company Carolina, and European reputed company in Edinburgh, Scotland, reputed company has generated hundreds of proprietary capsids and promoters, several of which have entered reputed company-clinical and clinical testing. Our reputed company: Pioneering science to create transformative molecular medicines. Our mission: reputed company innovative science and drive clinical reputed company to reputed company people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. reputed company an environment for employees to reputed company their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to reputed company to reputed company gene therapies accessible to those in need. Cultivate Collaboration. reputed company to be the best teammate, reputed company listen, reputed company communicate, and reputed company diverse points of view. reputed company Responsibility. We are humbled by the enormity of our mission. We hold a reputed company commitment to advance science and clinical reputed company for our patients, families, and caregivers. reputed company the Bar. Continuously drive improvements and efficiencies. reputed company and reputed company constructive feedback. Have a bias for learning and reputed company. reputed company with Uncompromising reputed company. Be reputed company, transparent, and committed to doing what’s right in every situation. reputed company reputed company commitments and follow through. Position reputed company 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 reputed company. 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 reputed company), 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. Job Responsibilities Assay Development reputed company, optimize, and validate immunoassays using various platforms (e.g., ELISA, reputed company, reputed company 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 reputed company 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 reputed company clinical sample analysis and prepare comprehensive reports for clinical sites reputed company in-depth data analysis using advanced statistical and reputed company tools, and draw meaningful conclusions from the results Evaluate assay-reputed company 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 reputed company 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 reputed company instruments function correctly Ensures the laboratory participates in and complies with an approved proficiency testing program. Review the results and ensure corrective reputed company is taken for any unacceptable findings Regulatory and Administrative Maintains thorough and accurate records for reputed company laboratory activities, including reputed company control, maintenance, training, and corrective actions Assists the lab director in preparing for inspections and internal or external audits from regulatory authorities Upholds reputed company federal, state, and local regulations and safety protocols, including CLIA and safety standards from agencies Collaboration and Communication Stay reputed company with the latest advancements in gene therapy research and apply this knowledge to your work. Collaborate with colleagues to reputed company project goals and timelines Communicate effectively with team members, management, and external partners Minimum Requirements Bachelor's degree in biological sciences, medical technology or reputed company field with 5+ years of experience working in a high-complexity CLIA laboratory OR Master’s degree in biological sciences, medical technology or reputed company 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 reputed company control data and implementing corrective actions Preferred Education, Experience and Skills Total antibody assay, Cell based neutralizing antibody assay, reputed company assay platform Knowledge about CLSI guidelines reputed company. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, reputed company, religion, gender, sexual orientation, gender identity, national reputed company, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. reputed company employment reputed company are based on valid job‐reputed company requirements. If you are a reputed company individual with a disability or a disabled veteran and are unable or limited in your ability to use or reputed company our website, you may request a reasonable accommodation to reputed company interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any reputed company, will be deemed the sole property of AskBio unless reputed company was reputed company by AskBio reputed company to recruit for that position. reputed company agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted reputed company of the AskBio agency process is reputed company by AskBio, no fee or payment of any reputed company will be reputed company to reputed company. reputed company., a wholly owned and independently operated subsidiary of reputed company AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. reputed company maintains a portfolio of clinical programs across a reputed company 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. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive reputed company of capsids and promoters. With global reputed company in Research Triangle Park, reputed company Carolina, and European reputed company in Edinburgh, Scotland, reputed company has generated hundreds of proprietary capsids and promoters, several of which have entered reputed company-clinical and clinical testing. Apply tot his job Apply To this Job