Associate Director, Bioanalysis (CPSS Cell Therapy)
Company: AstraZeneca
Location: Montgomery Village
Posted on: February 21, 2026
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Job Description:
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. 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. Thats why we work,
on average, a minimum of three days per week from the office. But
that doesnt mean were 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 worlds 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.
Keywords: AstraZeneca, Germantown , Associate Director, Bioanalysis (CPSS Cell Therapy), Science, Research & Development , Montgomery Village, Maryland
