As the fully-functional bioanalytical laboratory for R&D China, our mission in Development Science is to provide and ensure quality and compliant CK/PD/ADA/Nab/Biomarker data in a timely manner to support research and development of AZ Cell and Gene Therapy Projects, and facilitate filing and marketing of AZ assets in China and beyond.

Typical Accountabilities

• The principal bioanalysis scientist is responsible for:
• Serve as Cell and Gene Therapy Bioanalytical Subject Matter Expert (SME) member in China study team to partner on study design and executions, particularly around assay feasibility, sampling requirements, assay strategy, CRO selection, placement, contracting and oversight, data release, report generation, regulatory submissions, and CDE inspections
• Involve in the clinical bioanalysis projects as a principal scientist on the development, qualification/validation, and implementation of bioanalytical assays and sample analysis of Cell and Gene Therapy projects in a GxP environment of AZ Biolab
• Interaction with internal and external stakeholders to manage both in-house and outsourced Cell and Gene Therapy bioanalytical studies and facilitate their delivery and success
• Supporting lab management to continuously optimize lab operation procedures and expand bioanalytical capability and capacity
• Collaborate/interact with global and local bioanalytical teams for successful CK/IMG/PD/Biomarker bioanalysis for CRO selection, oversight, assay transfer, trouble shooting, validation, sample testing and data/result reporting
• Design, plan, execute and review experiments to support development and validation of new methodologies for CK/IMG/PD/Biomarker assays for Cell and Gene Therapy Trial samples
• Generate clinical sample analysis data with a high level of integrity and ethics and ensure regulatory requirements (GLP/GCP) and industry practices are followed
• Author method validation protocols/reports, bioanalytical sample testing reports, NDA/BLA dossier and Standard Operating Procedures
• Provide guidance and mentoring to junior lab members with experiment planning, troubleshooting, and data interpretation
• Present results at team/department meetings, prepare controlled documents and study plans/reports, and contribute to regulatory submission documents
• Manages resources and timelines to ensure timely delivery of results for clinical decision-making
• Serve as a scientific monitor for oversight of outsourced CK/IMG/PD/Biomarker bioanalytical work at CROs
• Independently apply basic scientific principles, attend scientific meetings, and keep abreast of cutting-edge techniques that can be implemented to enhance assay quality or throughput
• Team up with lab management and members to consistently improve operation and performance of the organization and grow team’s excellence in the bioanalysis
• Other tasks assigned by line manager.

Education, Qualifications, Skills and Experience

Essential

• Degree level education or equivalent experience
• Experience in pharmaceuticals or a related industry
• Excellent analytical, written and oral communications skills
• Fluent in written and spoken Chinese and English
• High ethical standards, trustworthy, operating with absolute discretion
• Strong collaborative, influencing and interpersonal
• Skills – curious to understand business environment
• Skilled at managing & using technology
• Ability to maintain and create professional networks with stakeholders
• Supplier qualification

Desirable

• B.Sc., M.Sc. or Ph.D. Degree in Biology, Biochemistry, pharmacology or related field with 12+ (B.Sc.), 10+ (M.Sc.) or 8+ (Ph.D.) years of pharma/Biotech industry experience
• Expertise in developing and troubleshooting transgene copy PCR (ddPCR or qPCR), immunoassays in some or all the following platforms: Flow Cytometry(traditional and spectral), Elispot, Hybridization-Ligation ECL ELISA, cell-based neutralization assays
• Experience with assay development, validation and/or sample testing for CK/IMG/PD/Biomarker in a GxP environment
• Attention to details and strong organization/teamwork skills

Date Posted

Closing Date

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.