Potency & Functional Bioassay Lead, Cell Therapy Analytics

AstraZeneca

Santa Monica (CA)

On-site

USD 138,000 - 207,000

Full time

2 days ago

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Job summary

AstraZeneca in Santa Monica seeks a scientific leader to drive potency and functional bioassay development within Analytical Sciences, supporting products from early development through commercialization.

You will set the technical strategy for phase-appropriate potency and bioassay methods, build capabilities in cell-line engineering and gene-editing analytics, and partner across CMC to ensure robust product characterization and regulatory readiness.

Qualifications

PhD in Immunology, Cell Biology, Molecular Biology, Biochemistry, Bioengineering, or related discipline with 6+ years of relevant experience; or MS with 8+ years; or BS with 10+ years.
Substantial analytical development experience in cell therapy, gene therapy, or biologics within a regulated environment.
Proven expertise developing and qualifying cell-based potency/functional assays suitable for QC use.
Strong knowledge of immune cell biology (T-cell and/or NK-cell) and relevant signaling mechanisms.
Hands-on experience with multiparametric flow cytometry and other cell-based analytical platforms.
Deep understanding of the analytical method lifecycle — development, qualification, validation, transfer, and lifecycle management.
Experience authoring analytical content for regulatory submissions.
Demonstrated ability to lead cross-functional scientific programs and influence technical strategy.

Responsibilities

Lead analytical strategy for potency and functional bioassays across the cell therapy portfolio, defining phase-appropriate approaches from early development to commercial launch.
Develop, qualify, validate, and lifecycle-manage cell-based potency and functional assays — including cytotoxicity, proliferation, activation, cytokine production, reporter-based assays, and multiparametric flow cytometry.
Build cell-line engineering and banking capabilities, including design of engineered target and reporter lines, clone selection, characterization, and critical reagent control to support transferable, commercial-ready methods.
Apply CRISPR/gene-editing, viral and non-viral delivery, and molecular biology expertise to enable analytics for autologous, allogeneic, and emerging in vivo therapies.
Drive method robustness using QbD, DOE, risk-based development, and sound statistical approaches.
Lead method transfer to internal QC, external labs, and manufacturing partners, including protocol and report authorship.
Partner with Process Development on process characterization, comparability, and linking process parameters to product quality attributes.
Serve as Analytical Lead on CMC program teams as appropriate, owning strategy, risks, timelines, and regulatory deliverables.
Author analytical sections of regulatory submissions (INDs through BLA) and responses to health authority queries.
Evaluate and implement emerging technologies and automation to improve robustness, throughput, and scalability.
Mentor and develop scientists, fostering strong experimental design and technical judgment across the team.