QC Functional Lead

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

As part of this role, successful candidate will complete a 6-month assignment at Wuxi China site, gaining valuable experience prior to returning to Singapore to support XDC Singapore operations.

Job Responsibilities:

• Ensure the successful and 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/ or method transfer, and ensure that the project is executed on time.
• Monitor project progress, identify risks, develop mitigation plans, and provide regular status updates to management and key stakeholders.
• Serve as the primary point of contact for clients regarding QC-related matters.
• Good understanding of clients requirements and ensure that QC processes and deliverables meet or exceed their expectations.
• Present QC findings, reports, and recommendations to clients in a clear and concise manner, facilitating effective decision-making.
• Build and maintain strong client relationships, acting as a trusted advisor and ensuring client satisfaction.
• Collaboration with the CMC team to fully understand the scope of the project and all vital aspects related to QC activities.
• Build effective partnership with stakeholders to move projects through all phases of the development and commercial stages.
• Prepare GMP documents, including but not limited to release and stability protocols, in-process sampling and testing protocols, special study protocol per clients requirement.
• Support regulatory inspections, customer audits, and regulatory submissions by providing project documentation, testing strategies, validation data, and subject matter expertise.

Preferred Qualifications

• Bachelor's, Master's, or PhD in Biochemistry, Biotechnology, Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
• 8+ years of experience in GMP biologics QC, analytical sciences, or quality operations, with demonstrated project management experience.
• Strong knowledge of biologics analytical techniques (HPLC/UPLC, CE, ELISA, Bioassays, PCR, SEC, icIEF, electrophoresis, etc.), GMP regulations, and technology transfer processes.
• Excellent project management and cross-functional collaboration skills.