QC Senior Scientist Functional Lead
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