Associate Director, Bioanalysis (Cell Therapy)

AstraZeneca; Santa Monica (CA); Hybrid; USD 142,000 - 214,000; Full time

Job summary

AstraZeneca in Santa Monica, CA, seeks a Bioanalytical Strategy Leader to set the strategy and drive execution of clinical bioanalytical endpoints for cell therapies. You will partner with clinicians, translational scientists, and external labs to deliver decision-grade data that informs go/no-go decisions and regulatory submissions.

You will lead assay development, tech transfer, data integration across PK/CK/PD and immunogenicity, and craft scientifically rigorous communications for internal

Qualifications

• PhD required with 7+ years of industry experience in cell therapy bioanalysis.
• Proven experience leading analysis of clinical biospecimens for trials.
• Experience with regulated bioanalysis PK/CK/PD and immunogenicity assessments.
• Ability to interpret complex datasets and present results to varied audiences.
• Strong cross-functional collaboration and regulatory awareness.
• Experience with data visualization tools and AI-enabled analysis is a plus.

Responsibilities

• Lead end-to-end bioanalytical strategy for cell therapy endpoints across PK/CK/PD and immunogenicity.
• Manage external partnerships with CROs and specialty labs to deliver high-quality data.
• Oversee assay development, qualification/validation, and tech transfer.
• Integrate datasets across programs and communicate insights to guide clinical/regulatory decisions.
• Prepare publications and presentations to advance program science.

Skills

Bioanalysis leadership

Data visualization

Cross-functional collaboration

Regulatory understanding

Cell therapy biology

AI tools experience

Education

PhD in immunology, cellular biology, or tumor biology

Tools

Cytobank

OMIQ

FCS Express

Tableau

Spotfire

JMP

Job description

Are you ready to lead bioanalysis that directly shapes how innovative cell therapies reach patients faster? 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.

Do you thrive on translating intricate biology into clear evidence that changes the course of development? This is your opportunity to build platforms, partnerships, and practices that set a new bar for cell therapy bioanalysis.

Accountabilities

Bioanalytical Strategy Leadership:

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.

External Partnerships And Vendor Excellence

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.

Assay Development And Tech Transfer Oversight

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.

Data Integration And Program Decision-Making

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. Can you see yourself unifying diverse data streams into a single, compelling story?

Scientific Communication And Influence

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.

Essential Skills/Experience

• 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.

Desirable Skills/Experience

• 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

The annual base pay for this position ranges from $142,377.60 - $213,566.40. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

When we put unexpected teams in the same room, we ignite ambitious 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.

Why AstraZeneca Here you will turn a productive, diverse pipeline into real treatments that improve patients’ lives, working in a setting that blends innovative science with practical, patient-first decision-making. We pair deep biology with modern technology, bring scientists, clinicians and data experts together to spark new ideas, and back bold moves with the resources of a leading company and the agility of a scale-up mindset. You will join a collaborative community that values kindness alongside ambition, where your leadership can both push the science forward and shape how teams across the ecosystem deliver for patients and society.

Date Posted

31-Aug-2026

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.