Sr. Research Associate, CLIA Lab Immunology

Opportunity for Secondment to AskBio

Were pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years the exact duration will be based on business needs and mutual agreement.

This secondment offers a unique chance to broaden your experience expand your knowledge and contribute meaningfully to AskBios mission: to advance gene therapy and change the lives of patients around the world.

If youre interested in exploring this opportunity we encourage you to:

• Speak with your direct manager to discuss your interest and alignment with your development goals.

• Apply directly using the link provided in the posting.

We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform peoples lives.

Our principles:

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 laboratorys 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

• Bachelors degree in biological sciences medical technology or related field with 5 years of experience working in a high-complexity CLIA laboratory OR Masters 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 jobrelated 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 or sending us an email at .