Sr. Research Associate, Clinical 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

Seeking a highly motivated and detail-oriented Senior Research Associate to join our Bioanalytical Group at the AskBio RTP site. 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. The candidate will report to the Associate Director within the Clinical Immunology (CI) functional group. 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.

Job Responsibilities

Assay Development

• Develop, optimize, and validate total antibody and neutralizing antibody assays 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 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 assay-related data provided by the CRO and derive meaningful conclusions.

Laboratory Operations

• Maintain a safe and organized laboratory environment

• Development and implementation of standard operating procedures (SOPs) for maintaining consistent research quality

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 health care or relevant scientific field and 5 years relevant work experience or Master's in healthcare or relevant scientific field and 2 years relevant work experience or 9 years relevant work experience

• Minimum of one year experience in troubleshooting assays

• Minimum of one year experience in Project management

• Previous experience with antibody assays, particularly MSD-based antibody assays, neutralizing antibody assays, ELISA

• Experience in working in a regulated laboratory environment; GxP

• Knowledge of industry best practices and regulatory requirements (Good Clinical Laboratory Practice, Good Laboratory Practice, Good Clinical Practices, CLIA and a solid understanding of Good Documentation Practice, 21 CFR Part 11, and laboratory standards relevant to clinical and preclinical laboratory research

• Strong collaborative skills. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team

• Ability to handle multiple projects/teams simultaneously

Preferred Skills & Abilities

• Ability to work independently in a fast-paced, highly interactive environment.

• Excellent verbal and written communication skills

• Prior experience with instrument maintenance and management

• Hands-on experience in immunoassay technology including ELISPOT is desirable

• Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team

• Experience with LIMS systems, especially LabVantage is desirable

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 ....

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.