Associate Director, Bioanalysis (CPSS Cell Therapy)
AstraZeneca, Gaithersburg, Maryland, us, 20883
Associate Director, Bioanalysis (CPSS Cell Therapy)
Introduction to role
Are you ready to make a significant impact in the field of cell therapy? Join our dynamic team at AstraZeneca as an Associate Director with in Clinical 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. Your expertise will 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, with special focus on autoimmune and rare diseases.
Identify, evaluate scientific and operational capabilities and establish partnerships with selected specialty laboratories and CROs for generation and analysis of bioanalytical data.
Lead and oversee assay development, qualification/validation and tech transfer (when appropriate) of cell therapy-related bioassays at CROs or using internal capabilities.
Interpret and integrate complex datasets within programs and across the cell therapy immunology and rare disease portfolio. 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, cell biology or a related field with 7+ years of relevant industry experience with strong background in cell therapy and demonstrated knowledge autoimmun e 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 (e.g. 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 of global regulatory expectations and fit for purpose analytical 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 as required.
Ability to prioritize multiple projects and task concurrently in a fast-paced environment.
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.
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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, with special focus on autoimmune and rare diseases.
Identify, evaluate scientific and operational capabilities and establish partnerships with selected specialty laboratories and CROs for generation and analysis of bioanalytical data.
Lead and oversee assay development, qualification/validation and tech transfer (when appropriate) of cell therapy-related bioassays at CROs or using internal capabilities.
Interpret and integrate complex datasets within programs and across the cell therapy immunology and rare disease portfolio. 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, cell biology or a related field with 7+ years of relevant industry experience with strong background in cell therapy and demonstrated knowledge autoimmun e 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 (e.g. 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 of global regulatory expectations and fit for purpose analytical 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 as required.
Ability to prioritize multiple projects and task concurrently in a fast-paced environment.
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.
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