Associate Director, Bioanalysis (Cell Therapy)

AstraZeneca•Santa Monica, CA

2d•$142,378 - $213,566•Hybrid

About The Position

In this role, you will set the strategy and drive the execution of clinical bioanalytical endpoints that inform go/no-go decisions, de-risk development, and accelerate regulatory submissions! You will join a high-energy team advancing next-generation cell therapies, partnering closely with clinicians, translational scientists, and external labs to deliver robust, decision-grade data. This is your opportunity to build platforms, partnerships, and practices that set a new bar for cell therapy bioanalysis.

Requirements

PhD degree in immunology, cellular and/or tumor biology or a related field with 7+ years of relevant industry experience with strong background in cell therapy
Demonstrated experience leading/directing analysis of clinical biospecimens to support clinical trials.
Proven experience in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments
Able to evaluate and interpret complex data sets using analysis and visualization software (i.e. Cytobank/OMIQ/FCS Express, Tableau/Spotfire/JMP), experience with AI tools is a plus.
Work cross-functionally and collaboratively with project team members.
Deep understanding of cell therapy biology and up to date with latest analytical methods applicable to characterization of cell therapy products and mechanism of action.
Understanding of global regulatory expectations and analytical requirements to support regulatory filings.
Experience managing assay development teams, leading all aspects of tech transfers, scientific quality and study conduct internally and at CROs.
Ability to interpret complex datasets and outstanding ability to communicate results verbally, in writing and in presentations adapting to different audiences as required.
Ability to prioritize multiple projects and task concurrently in a fast-paced environment.

Nice To Haves

Track record of leading bioanalytical strategies for cell therapy programs from early development through clinical phases
Experience implementing complex flow cytometry, single-cell, or molecular assays for mechanism-of-action and biomarker readouts
Familiarity with automation, digital data pipelines, and data governance for regulated bioanalysis
Prior authorship of peer-reviewed publications and presentations at major scientific conferences
Experience negotiating and managing master service agreements and quality agreements with CROs and specialty labs
Demonstrated capability to mentor and grow high-performing scientific teams

Responsibilities

Develop and implement end-to-end bioanalytical strategies supporting clinical assay endpoints across PK/CK/PD, immunogenicity (humoral, cellular, viral), and biomarkers for cell and gene products (CAR/TCR/in vivo). Deliver strategies that withstand regulatory scrutiny and enable confident clinical decision-making.
Identify, evaluate, and establish relationships with specialty laboratories and CROs. Orchestrate external capabilities to generate high-quality bioanalytical data at pace, ensuring scientific rigor and operational reliability.
Lead assay development, qualification/validation, and tech transfer for cell therapy bioassays, deploying the right work to CROs or internal teams. Build scalable, reproducible methods that shorten timelines and increase assay robustness.
Interpret and integrate complex datasets within programs and across the portfolio. Provide streamlined written and verbal updates to collaborators, transforming data into clear recommendations that guide clinical and regulatory strategy.
Compose publication strategies and prepare data for internal and external scientific forums. Amplify the impact of program findings through high-quality presentations and publications that position AstraZeneca at the forefront of cell therapy science.