Associate Scientist, Immunology

askbio; Durham (NC); On-site; USD 100,000 - 135,000; Full time

Job summary

AskBio Inc. (AskBio) is a fully integrated gene therapy company focused on developing medicines for neuromuscular, CNS, and metabolic diseases.

The Associate Scientist will develop and validate binding and neutralizing antibody assays on preclinical and clinical samples to support gene therapy programs. The successful candidate will have hands-on experience in immune assay techniques and work with cross-functional teams to ensure regulatory standards are met.

Qualifications

• Bachelor’s degree in Immunology, Biology, Biochemistry, Biotechnology, Virology or related field with 8+ years’ relevant work experience; or Master’s degree with 4+ years’
• Experience in Pharma or CRO industry
• Experience in development and validation of ligand binding and neutralizing antibody assays following GLP
• Experience with mammalian cell culture and performing analytical assays using MSD platform
• Knowledge of FDA guidelines and immunogenicity assay development and Companion Diagnostics
• Proficiency with MS Office tools and strong communication skills
• Self-motivated, organized, and able to work independently as well as in a team

Responsibilities

• Design and execute complex assays related to neutralizing and total antibody development using cell-based techniques
• Optimize protocols to ensure accuracy, reproducibility, and regulatory compliance; perform validation
• Analyze clinical samples and prepare reports for clinical sites
• Perform data analysis using statistics and bioinformatics tools and draw conclusions
• Prepare reports, presentations, and manuscripts for internal and external stakeholders
• Stay current with gene therapy research advancements and apply to work
• Collaborate with researchers, engineers, and team members to meet project goals
• Develop and implement SOPs for consistent research quality
• Assist with regulatory filings
• May supervise and mentor junior staff

Skills

Binding antibody assays

Neutralizing antibody assays

Cell culture

Aseptic techniques

Regulatory compliance (FDA/GLP/CLIA)

Data analysis (statistics, bioinfo)

Documentation / report writing

Cross-functional collaboration

Education

Bachelor’s degree with 8+ years experience

Master’s degree with 4+ years experience

Tools

MSD platform

MS Office (Word/Excel/PowerPoint)

Job description

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 Associate Scientist 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 binding antibody assays, 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.

This position is on site in RTP, NC and reports to an Associate Director, Clinical Immunology.

Job Responsibilities

• Independently design and execute complex assays related to neutralizing and total antibody development, utilizing strong scientific expertise and knowledge of adeno viral vector and cell-based techniques
• Optimize and troubleshoot experimental protocols to ensure accuracy, reproducibility, and efficiency. Perform neutralizing and total antibody assay validation to meet FDA and CLIA guidelines
• 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
• Prepare comprehensive reports, presentations, and manuscripts summarizing research findings for internal and external stakeholders
• Stay current with the latest advancements in gene therapy research and apply this knowledge to your work
• Collaborate effectively with research scientists, engineers, and other team members to achieve project goals
• Develop and implement standard operating procedures (SOPs) for maintaining consistent research quality
• Assist with the preparation and submission of regulatory filings
• May supervise and mentor junior research staff

Minimum Requirements

• Bachelor’s degree in Immunology, Biology, Biochemistry, Biotechnology, Virology or related field with 8+ years’ relevant work experience; or Master’s degree in Immunology, Biology, Biochemistry, Biotechnology, Virology or related field with 4+ years’ relevant work experience
• Prior experience in Pharma or CRO industry
• Basic lab skills, such as adhering GCLP, biosafety and chemical use guidelines (training provided) and making reagents at desired dilutions or concentrations
• Demonstrated experience in the performing development and validation of ligand binding and neutralizing antibody assay following GLP compliance
• Experience with mammalian cell culture and performing analytical assays using MSD platform
• Knowledge of industry practices for the development, qualification/ validation of immunogenicity assays and FDA guidelines
• Knowledge of Companion Diagnostics
• Proficiency with MS Office tools (Word, Excel, and PowerPoint)
• Self-motivated, organized, and individual capable of working independently as well as an active team contributor
• Strong oral and written communication skills
• Excellent interpersonal skills with the ability to interact effectively with teams, internally and externally

Preferred Education, Experience and Skills

• Experience in performing Western blots and protein purification. and processing/handling primary cells such as PBMCs

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.