Lead QC Scientist: Methods, Transfer & Client Partnership

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 110,000 - 170,000; Full time

Job summary

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking an experienced QC Project Lead to ensure delivery of QC projects, establish method readiness, and maintain testing capabilities for biologics. The role requires strong client relationship skills and subject-matter expertise in QC processes.

You will manage schedules, monitor risks, and present findings to clients, while collaborating with the CMC team and preparing GMP documentation.

Qualifications

• 8+ years of experience in GMP biologics QC, analytical sciences, or quality operations.
• Strong knowledge of biologics analytical techniques and GMP regulations.
• Experience with technology transfer and project management.

Responsibilities

• Prepare and track the schedule of QC activities including method qualification/validation and method transfer.
• Monitor project progress, identify risks, develop mitigation plans, and provide updates.
• Ensure QC processes and deliverables meet client requirements and expectations.
• Present QC findings, reports, and recommendations to clients clearly.
• Collaborate with CMC team to understand project scope and QC activities.
• Build partnerships with stakeholders to move projects through development and commercial stages.
• Prepare GMP documents such as release/stability protocols and sampling/testing protocols.
• Support regulatory inspections, audits, and submissions with documentation and data.

Skills

GMP biologics QC

Analytical techniques

Project management

Cross-functional collaboration

HPLC/UPLC

CE

ELISA

Bioassays

PCR

SEC

icIEF

Electrophoresis

Education

Bachelor's degree in Biochemistry/ Biotechnology/ Analytical Chemistry/ Pharmaceutical Sciences

Master's degree in related field

PhD in related discipline

Tools

LIMS

Job description

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking an experienced QC Project Lead to ensure delivery of QC projects, establish method readiness, and maintain testing capabilities for biologics. The role requires strong client relationship skills and subject-matter expertise in QC processes.

You will manage schedules, monitor risks, and present findings to clients, while collaborating with the CMC team and preparing GMP documentation.