QC Functional Lead – Global Biologics, Client-Facing

WuXi XDC; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

WuXi XDC is seeking an experienced QC professional to lead biologics QC projects. The role involves ensuring method readiness, validation, and transfer, while maintaining testing capabilities for clinical and commercial products.

You will act as the main client contact and collaborate with the CMC team to align on project scope and regulatory needs. The ideal candidate will bring 8+ years in GMP biologics QC with strong analytical skills in HPLC/UPLC, CE, and ELISA, and proven project management

Qualifications

• 8+ years of GMP biologics QC, analytical sciences, or quality operations with project management experience.
• Strong knowledge of biologics analytical techniques (HPLC/UPLC, CE, ELISA, Bioassays, PCR, SEC, icIEF) and GMP regulations.
• Excellent project management and cross-functional collaboration skills.

Responsibilities

• Ensure timely delivery of QC projects by establishing method readiness and maintaining testing capabilities for clinical and commercial products.
• Prepare and track the schedule of QC activities, including method qualification/validation and method transfer.
• Monitor project progress, identify risks, and provide regular status updates to management and stakeholders.
• Serve as the primary point of contact for clients regarding QC-related matters.
• Collaborate with the CMC team to understand project scope and vital QC aspects.
• Prepare GMP documents, including release and stability protocols, in-process sampling and testing protocols.
• Support regulatory inspections, audits, and submissions with project documentation and validation data.

Skills

GMP QC experience

Project management

Cross-functional collaboration

Biologics analytical techniques

Education

Bachelor’s degree in Biochemistry/related field

Tools

HPLC/UPLC

CE

ELISA

PCR

SEC

icIEF

Job description

WuXi XDC is seeking an experienced QC professional to lead biologics QC projects. The role involves ensuring method readiness, validation, and transfer, while maintaining testing capabilities for clinical and commercial products.

You will act as the main client contact and collaborate with the CMC team to align on project scope and regulatory needs. The ideal candidate will bring 8+ years in GMP biologics QC with strong analytical skills in HPLC/UPLC, CE, and ELISA, and proven project management