Position Summary

We are seeking a highly motivated Senior Scientist to join our Analytical Development (AD) team. The successful candidate should have strong expertise in immuno-oncology and will be focused on focus on the development of fit-for-purpose CMC assays using flow cytometry and cell-based immunoassays, to characterize engineered TCR-T cell drug substance and drug product. This role is based out of Santa Monica, CA and reports directly to the Director, Analytical Development.

Essential Functions and Responsibilities

• Design and develop robust analytical assays for characterizing T-cell therapy drug substance and drug products using flow cytometers and/or other immunoassays.
• Author assay development and qualification reports with solid datasets to evaluate assay characteristics.
• Perform analytical assays to provide insights for process and product.
• Drive assay life cycle, including assay optimization, transfer, and qualification.
• Work with Tech Operations cross-functional teams to draft study protocols, change controls and technical reports.
• Author and review relevant CMC sections for regulatory submissions.
• Lead projects and represent bioassay function and effectively communicate progress or issues in CMC sub-team meetings.
• Perform routine assays as a QC personnel for drug product release and characterization.

Required Skills/Abilities

• PhD in Immunology, Oncology, Cell Biology, or related discipline with 2 years of relevant academic or industry experience
• In-depth knowledge in immunology and cell therapy with hands-on experience working with T cells is preferred.
• Extensive hands-on experience in executing assays and analyzing data using multi-color flow cytometry ( 10 colors).
• First-hand experience in different cell-based assays (e.g., Live imaging, ELISA, or MSD) is preferred.
• Prior working experience in a regulated environment (GLP, GMP or QC) is a plus.
• Technical-driven, detail-oriented data analysis skills and record keeping abilities.
• Excellent verbal, written and presentation skills for scientific studies and projects.
• Enjoy a fast-paced, dynamic company environment and able to adjust workload based upon changing priorities.

The anticipated salary range for candidates who will work in Santa Monica, CA is $125,000 to $149,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

Note: At this time, Neogene is not sponsoring VISAs.