AstraZeneca · 8 hours ago
Associate Director, Bioanalysis (CPSS Cell Therapy)
Gaithersburg, MD
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$135K/yr - $203K/yr
7+ years expAstraZeneca is a leading biopharmaceutical company focused on pioneering new frontiers in medicine. They are seeking an Associate Director within the Clinical Pharmacology and Safety Sciences Cell Therapy team to lead the design and implementation of bioanalytical strategies that support clinical assay endpoints for their cell therapy pipeline.
BiotechnologyMedical DeviceHealthcarePharmaceuticalBiopharmaHealth CareMedicalPrecision Medicine
Responsibilities
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
Qualification
Required
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 autoimmune 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 of global regulatory expectations and fitforpurpose 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
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
H1B Sponsorship
AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
2026-02-12
2026-02-12
2026-02-12
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