Associate Scientist, Immunology
About The Position
This role is a secondment opportunity at AskBio, available for a time period determined by leadership at both Bayer and AskBio, typically ranging from one to two years. This secondment offers a chance to broaden experience, expand knowledge, and contribute to AskBio’s mission of advancing gene therapy. The position is for a highly motivated and detail-oriented Associate Scientist to join the Bioanalytical Group. The successful candidate will develop and validate binding antibody and neutralizing antibody assays for preclinical and clinical samples to support gene therapy programs. This requires hands-on experience in immune assay techniques and a basic understanding of gene therapy research. The candidate will work with cross-functional teams to ensure assays meet regulatory standards and contribute to gene therapy project advancement. The ideal candidate has a strong background in binding antibody assays, cell culture, and aseptic techniques, and will work in a dynamic, fast-paced environment. Antibody assay development, qualification, and validation will be performed in compliance with GCLP, GLP, CLIA, and relevant regulations. This position is on-site in RTP, NC and reports to an Associate Director, Clinical Immunology.
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
Nice To Haves
- Experience in performing Western blots and protein purification.
- Experience in processing/handling primary cells such as PBMCs
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
