• Single point of contact between BeiGene clinical teams and bioanalytical labs (CROs).

• Act as clinical bioanalysis project manager in charge of biologics. Work closely with other functional groups in BeiGene to establish innovative development portfolio of biologics.

• Manage timelines, budget, and logistics operations of the outsourced activities, ensure quality and GLP/GCP compliance. Maintain 100% compliance with all internal and external requirements.

• Ability to manage multiple projects to meet aggressive timelines are required skills.

• Support lab selection based on project specificity. Maintain effective communication with outsourcing management and CROs.

• Provide technical instruction to the team. Support trouble shooting in bio-analytical assay transfer, method validation and sample analysis.

• Manage and communicate project and budget status, timeline and roadblocks to senior leaders and stakeholders.

• Identify and evaluate new CROs in China and ex-China according to clinical bioanalysis needs. Act as subject matter expert for bioanalytical labs qualification.

• Involve in any regulatory submission or inspection.

• Other duties as assigned

• A bachelor with minimum 5 years or Master with 3 years of working experience in relevant scientific field or significant relevant experience and knowledge of Immunology, and/ or Immuno-Oncology from working in the life science sector.

• Extensive experience in Elisa, MSD and/or cell-based assay is a must and previous experience with ADC products is a plus.

• Familiar with the assay development, validation, and sample analysis requirements in compliance with NMPA, FDA, EMA and ICH GLP/GCP guidance.

• Good oral and written communication skills are required.