Senior Scientist I, Bioanalysis and Translational Medicine Full-time

Bioanalysis And Translational Medicine Role

The Bioanalysis and Translational Medicine department centers on data-driven bioanalysis and translational research, leveraging molecular/protein assays, cellular function and phenotyping, and biomarker with PK/PD platforms to support cell therapy programs including CAR-T and mRNA-LNP/lentiviral in vivo CAR.

The role holder will be accountable for method establishment and sample analysis for IIT-stage clinical samples by qPCR/ddPCR, including CAR VCN, RCL and other biomarkers. This role requires experience in the CAR-T industry and a background in PCR techniques to support analytical method development, transfer, validation, sample testing, and data analysis; it also involves assisting the Bioanalysis and Translational Medicine department with external project management. The role holder is accountable for ensuring that all activities are delivered demonstrating behaviors and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures, including compliant management of Budget, Safety, Health and Environment.

Role & Responsibilities

• Sample pre-processing and traceability: Define and execute standards for collection, transport, storage, and receipt of blood/plasma, bone marrow, tissue (fresh/FFPE), and cellular samples; perform DNA/RNA extraction and QC (Qubit, A260/280); establish standardized workflows to ensure end-to-end traceability and compliance.
• Sample testing: Conduct qPCR/ddPCR assays per SOPs (VCN, persistence/clearance, target mRNA expression, RCL); maintain a comprehensive control system (positive/negative controls, NTC, spike in standards); design and optimize primers/probes, short amplicon strategies, and anti inhibition approaches as needed to ensure batch stability and reliable results.
• Manage external alliance: Define technical plans and quality requirements; select and evaluate CROs; Work effectively with procurement to contract the biomarker operations to deliver fit-purpose laboratory testing from receipt delivery of results, compliant with clinical sample testing guidelines.
• Data analysis and delivery: Perform statistical analysis and interpretation; integrate with flow cytometry, ELISA, and PK/PD data; deliver standardized reports and actionable translational conclusions.
• Complete protocols, reports, and other documentation during the method establishment process; write experimental records accurately and promptly, ensuring the correctness and completeness of experimental data and reports.
• Clinical project support: review clinical protocols and relevant sections of ICFs, assist HGR application, data management, and other processes by working closely with clinical team and other supporting functions.

• Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance.

Requirements

Essential:

• Master's degree or above in molecular biology, genomics, bioinformatics, immunology, or a related field; at least 5 years of experience in molecular testing, translational medicine, or clinical laboratory work.
• Having experience in developing, validating, and testing PCR-based analytical methods for clinical samples, including independently establishing new methods.
• Knowledge of clinical testing procedures and applicable laboratory testing regulations such Good Clinical Practice, Good Clinical Practice, CAP.
• Experience of working with testing partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
• Ability to identify risks and escalate appropriately

Skills & Capabilities

• Good interpersonal skills and ability to act as an ambassador for Bioanalysis and Translational Medicine internally and externally
• Ability to interact successfully with multiple partners across functional boundaries
• Ability to work independently, designing, and executing tasks
• A confident team player who is assertive but willing to listen and learn from the views of others
• Excellent organizational skills, with the proven ability to deliver high quality work under pressure and against tight timelines

Desirable:

• An understanding of drug and companion diagnostic assay co-development and commercialization and experience working in early and late phase projects
• Demonstrates a clear understanding of the scientific rationale underpinning PK/PD testing in cell therapy.
• Demonstrated experience in developing, optimizing, and validating PCR-based assay.
• Possesses practical experience in NGS, IHC, and ISH/FISH, or demonstrates solid theoretical and methodological knowledge in these areas.