Associate Director, Analytical Sciences – Potency & Bioassay Development

AstraZeneca; Santa Monica (CA); Vor Ort; USD 138.000 - 207.000; Vollzeit

Benefits dieser Stelle

Short-term incentive bonuses

Equity-based awards

Commissions for sales roles

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Cell therapy analytics

Analytical development

Flow cytometry

CRISPR/gene editing

Statistical methods

Team leadership

Ausbildung

PhD in Immunology / Cell Biology / Biochemistry

MS in related discipline

BS in related discipline

Tools

Multiparametric flow cytometry

qPCR / ddPCR

NGS

JMP / Prism

Jobbeschreibung

At AstraZeneca, we are pushing the boundaries of science to deliver life-changing cell and gene therapies to patients. We are seeking a scientific leader to drive potency and functional bioassay development within our Analytical Sciences organization, supporting products from early development through commercialization.

In this role, you will set the technical strategy for phase-appropriate potency and bioassay methods, build organizational capability in cell-line engineering and gene-editing-enabled analytics, and partner across CMC functions to ensure robust product characterization, release, stability, and comparability. You may also serve as Analytical Lead for programs advancing toward late-stage development and launch. This role is based out of Santa Monica, CA and reports to the Director, Product Analytical Sciences.

What You’ll Do

• 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.

Essential 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.
• Strong communication, mentorship, and scientific leadership skills.

Preferred skills

• Direct experience engineering, characterizing, and banking mammalian cell lines as assay substrates, targets, or reporters.
• Experience establishing critical reagent and cell bank strategies for late stage/commercial methods.
• Experience with CRISPR and gene-editing analytics (knockout confirmation, copy number, off-target assessment).
• Broad molecular biology toolkit: PCR, qPCR, ddPCR, NGS, cloning.
• Experience across autologous, allogeneic, and in vivo modalities, including viral-vector characterization.
• Late-stage analytical experience supporting comparability, validation, or BLA filings.
• Prior role as Analytical/Technical Lead on a CMC team.
• Experience implementing lab automation or high-throughput platforms.
• Proficiency with JMP, Prism, FlowJo, SoftMax Pro, or equivalent.

The annual base pay for this position ranges from $138K to $207K. 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.

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.