Senior Scientist I, Bioanalysis and Translational Medicine Full-time

Clinical Samples Methodologist

The role holder will be accountable for method establishment and sample analysis for IIT-stage clinical samples by LBA methods, including cytokines (ELISA/MSD), anti-drug antibodies (ADA), neutralizing antibodies (Nab), and other serological biomarkers. This role requires experience in the CAR T industry and a background in ELISA/MSD 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

• Establish and validate bioassays for anti-drug antibody (ADA) /neutralizing antibody (Nab) according to project requirements.
• Conduct clinical sample detection and data analysis, including cytokines, ADA, Nab, sBCMA, and other ELISA or MSD-based method according to clinical protocols.
• 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.
• Manage external alliance, support Bioanalysis and Translational Medicine activities including assay transfer, vendor evaluation and collaborations; 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.
• 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 in biology, immunology, or related fields required, and have a background of bioanalysis in cell therapy.
• At least 3 years of experience in developing, validating, and testing ELISA/ADA/Nab related analysis methods for clinical samples, with experience in establishing new methods independently.
• Knowledge of clinical testing procedures and applicable laboratory testing regulations such 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, 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 experience working in early and late phase projects
• Understand the principle of LBA (such as ELISA and MSD) methodology.
• Understand the scientific rationale of biomarker testing.
• Experience of ELISA/MSD assay development, optimization and validation.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.