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Associate Director, Bioanalysis (CPSS Cell Therapy)

Plats Gaithersburg, Maryland, USA Jobb-id R-245862 Datum inlagd 02/12/2026

AssociateDirector, Bioanalysis(CPSSCell Therapy)

Introduction to role

Are you ready to make a significantimpact in the field ofcell therapy? Join our dynamic team at AstraZeneca as an AssociateDirectorwithinClinical Pharmacology and Safety Sciences (CPSS) Cell Therapy team, where you will lead the design and implementation of robust bioanalytical strategies to support clinical assay endpoints. Yourexpertisewill be crucial in advancing our cell therapy pipeline and transforming the lives of patients.This position is based in either Santa Monica, CA or Gaithersburg, MD.

Accountabilities

  • Lead design and implementation of robust bioanalytical strategies to support clinical assay endpoints, including but not limited to PK/CK/PD, immunogenicity and biomarkers related to cell therapy products to support the AstraZeneca cell therapy pipeline, withspecial focus on autoimmune and rare diseases.

  • Identify, evaluate scientific and operationalcapabilitiesandestablishpartnerships with selected specialty laboratories and CROs for generation and analysis of bioanalytical data.

  • Lead and oversee assay development, qualification/validationand tech transfer (whenappropriate)of cell therapy-related bioassays at CROs or using internal capabilities.

  • Interpret and integrate complex datasets within programs and across the cell therapyimmunology and rare diseaseportfolio. Provide written and verbal updates to key stakeholders.

  • Contribute to publication strategy, prepare data for publication or presentations in internal/external scientific conferences.

Essential Skills/Experience

  • PhD degree in immunology, cellbiologyor a related field with 7+ years of relevant industry experience with strong background in cell therapyanddemonstratedknowledgeautoimmune diseases

  • Demonstrated experience managing/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).

  • Work cross-functionally and collaboratively with project stakeholders.

  • 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 ofglobal regulatory expectations andfitforpurposeanalytical requirements, with a record of supporting compliant data packages for IND/CTA/BLA filings.

  • Experience managing assay development teams, overseeing tech transfers, scientific quality and study conduct internally and at CROs.

  • Ability to interpret complex datasets and exceptional ability to communicate results verbally, in writing and in presentations adapting to different audiences asrequired.

  • Ability to prioritize multiple projects andtaskconcurrently in a fast-paced environment.

#LI-onsite #CellTherapy

When we put unexpected teams in the same room, we unleash 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.

At AstraZeneca, we are dedicated to following the science and pioneering new frontiers. Our Oncology team is driven by an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. We fuse cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver six new molecular entities by 2025. Our collaborative research environment unites some of the world's foremost medical centers, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career while making a meaningful impact on millions of lives.

Ready to make a difference? Apply now!

The annual base salary for this position ranges from $135,058.40 - 202,587.60. 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.

Date Posted

11-Feb-2026

Closing Date

12-Mar-2026

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.



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 authorisation and employment eligibility verification requirements.

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