Associate Director, Bioanalysis (CPSS Cell Therapy)

Role Summary

Associate Director, Bioanalysis (CPSS Cell Therapy) at AstraZeneca. Lead design and implementation of robust bioanalytical strategies to support clinical assay endpoints within CPSS Cell Therapy, contributing to the cell therapy pipeline and patient outcomes.

Responsibilities

• Lead design and implementation of bioanalytical strategies to support clinical assay endpoints, including PK/CK/PD, immunogenicity and biomarkers related to cell therapy products to support the AstraZeneca cell therapy pipeline.
• Evaluate scientific and operational capabilities and establish partnerships with selected specialty laboratories and CROs for generation and analysis of bioanalytical data.
• Lead assay development, qualification/validation and tech transfer of cell therapy-related bioassays at CROs or using internal capabilities.
• Interpret and integrate complex datasets within programs and across the cell therapy portfolio. Provide written and verbal updates to key stakeholders.
• Contribute to publication strategy, prepare data for publication or presentations in internal/external scientific conferences.

Qualifications

• PhD degree in immunology, cellular and tumor biology or a related field with 7+ years of relevant industry experience with background in cell therapy
• Demonstrated experience managing/directing analysis of clinical biospecimens to support clinical trials.
• Experience with regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments
• 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.
• Experience with 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, overseeing tech transfers, scientific quality and study conduct internally and at CROs.
• Interpret complex datasets to communicate results verbally, in writing and in presentations adapting to different audiences.
• Ability to prioritize multiple projects and task concurrently in a fast-paced environment.

Skills

• Bioanalysis strategy development
• Assay development, qualification/validation, tech transfer
• Data interpretation and visualization
• Cross-functional collaboration
• Regulatory science and compliance

Education

• PhD in immunology, cellular and tumor biology or related field