QC Senior Scientist Functional Lead

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

About the role

Ensure the successful and timely delivery of QC projects by establishing method readiness and maintaining testing capabilities for clinical and commercial products. Serve as the primary point of contact for clients regarding QC-related matters, building and maintaining strong client relationships while acting as a trusted advisor.

Key responsibilities

• 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
• Ensure good understanding of client's requirements and 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
• Collaborate 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 client's requirement
• Support regulatory inspections, customer audits, and regulatory submissions by providing project documentation, testing strategies, validation data, and subject matter expertise

About you

• 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
• 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