Sr. Research Associate, CLIA Lab Immunology

AskBio 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. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision: Pioneering science to create transformative molecular medicines.

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

Our principles:

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

Our values:

• 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.

Position Summary

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.

Job 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

Minimum 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

Preferred Education, Experience and Skills

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

AskBio Inc. (AskBio) 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. All employment decisions are based on valid job-related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at [email protected].

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 medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.