Senior Bioanalytical Scientist(J25171)

职位描述

We are seeking an experienced and highly motivated Senior Bioanalytical Scientist to join our team. The ideal candidate will possess extensive experience in LC-MS based proteomics or bioanalysis, particularly in support of IND-enabling and clinical studies, and demonstrate strong project management, regulatory knowledge, and leadership capabilities. Key Responsibilities • Lead and execute LC–MS/MS–based proteomics or bioanalytical studies supporting IND and other regulatory submissions, ensuring high-quality data generation and timely project delivery. • Ensure all work complies with relevant regulatory guidance, including ICH, FDA, and NMPA/CDE bioanalytical guidelines. • Manage project timelines, coordinate resources across functional teams, and ensure efficient project execution. • Lead and mentor a team of scientists, fostering collaboration, providing technical guidance, and driving successful project completion. • Identify and resolve technical and operational challenges in complex, multi-project environments. • Maintain strict adherence to internal quality systems, SOPs, and compliance requirements. • Communicate effectively with internal stakeholders, project teams, clients, and regulatory authorities when required.

任职要求

• Qualifications
• Master’s or PhD degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Master’s degree candidates should have >5 years of relevant industry experience.
• Extensive experience in LC–MS/MS-based proteomics or bioanalysis.
• Familiarity with ICH, FDA, and NMPA/CDE bioanalytical guidance.
• Proven project management experience, including resource coordination and timeline management.
• Strong problem-solving abilities and the capacity to work effectively in fast-paced, multi-project environments.
• Excellent written and verbal communication skills in both English and Chinese.
• Preferred Qualifications
• Experience supporting both preclinical and clinical bioanalytical studies.
• Experience in targeted proteomics for absolute protein quantification.
• Extensive experience in large molecule bioanalysis, including monoclonal antibodies and antibody–drug conjugates (ADCs).
• Experience in high-throughput bioanalysis and method development.
• Prior experience in a large CRO environment is a plus.