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
