Senior Scientist, Analytical Development

3 weeks ago

Santa Monica, California, United States Neogene Therapeutics Full time

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

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.

DE&I Statement

Headline: We embrace our individual differences.

"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:

Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
A collaborative culture that leverages the diverse perspectives of employees and supports courage
Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist."

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