Senior Scientist, Analytical Development

We are seeking a 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.

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.

Education and Experience

• 7+ years with BS / BA; 5+ years with MS / MA; 2+ years with PhD in Immunology, Oncology, Cell Biology, or related discipline
• 1+ years of management 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.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.

That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible.

We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $125,000 to $149,000 . However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience.

If hired, employee will be in an at-will position and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department / team performance, and market factors.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.

We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.