Senior Bioanalytical Project Manager

This role serves as a subject matter expert (SME) in bioanalysis, including bioanalytical strategy, assay development, validation, sample analysis and data transfer for large molecules, e.g.: mAb, Bi-Specifics, ADCs, and Cell Therapy. The role requires in-depth knowledge of bioanalysis, strong project management skills, efficient communications and the ability to effectively navigate the regulatory landscape in China. It involves close collaboration with both global and local teams to ensure successful execution of bioanalytical strategies of clinical projects and studies.

Typical Accountabilities

• Strategy and Implementation: Driving global and China-led bioanalytical project strategy and implementing harmonized assay for data integration. This involves developing and implementing strategies to ensure the timely delivery and successful integration of bioanalytical data to the downstream quantitative analysis
• Collaboration and Team Interaction: Working with global and local project teams to ensure successful and smooth running of bioanalyses for PK/ADA/PD/Biomarker. This involves coordinating with cross-function teams and stakeholders to ensure the successful execution of bioanalytical plans of all projects.
• CRO Selection and Oversight: Managing the selection and oversight of CROs for bioanalytical work. Act as SME for bioanalytical labs qualifications. Support trouble shooting in bioanalytical assay transfer, method validation, sample analyses, and data/result reporting. Ensure high quality and GLP/GCP compliance, to meet internal and external regulatory requirements.
• Budget and Resource Management: Planning and managing budgets, FTE resources, and timelines to ensure timely and high-quality delivery of outsourced work from CROs in the clinical project team. This involves overseeing the financial and human resource aspects of bioanalytical projects.
• Scientific Monitoring and Liaison: Serving as a scientific monitor and technical liaison for oversight of outsourced PK/ADA/PD/Biomarker bioanalytical work at CROs. This involves ensuring that the bioanalytical work meets scientific and technical standards, as well as supporting regulatory submission dossiers and inspection.

Education, Qualifications, Skills and Experience

Essential

• M.Sc. or Ph.D. Degree in biology, biochemistry, pharmacology, immunology or related fields with 10+ (M.Sc.) or 8+ (Ph.D.) years of pharma/Biotech/CRO industry experience
• Familiar with PK/ADA/PD/Biomarker assay development and validation of biologics including mAb, Bi-Specifics, ADC and Cell Therapy in compliance with NMPA, FDA, EMA and ICH GLP/GCP guidance
• Deep knowledge in ELISA, Meso Scale Discovery (MSD), LC-MS, PCR and Flow Cytometry
• Fluent in written and spoken Chinese and English
• High ethical standards, trustworthy, operating with absolute discretion
• Strong collaborative, influencing and interpersonal skills

Desirable

• Rich experience and skills in management of outsourced CROs, insourcing projects and troubleshooting LBA based immunoassays and LC-MS based assays
• Technical expertise with assay development, validation, transfer and sample testing for PK/ADA/PD/Biomarker in a GxP environment
• Experience in CRO audits and bioanalysis regulatory inspection
• Experiences in CRO vendor qualification, bidding and contracting
• Project management experiences in the GXP lab of regulated bioanalysis
• Extensive experience as a BioA rep in the core team managing or designing complex clinical trials which require close monitoring

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 authorisation and employment eligibility verification requirements.