全职 QC Senior Scientist - AST (Analytical Science - Technology) 工作, 薪水, WuXi XDC 公司招聘中 - Ricebowl

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.

Responsibilities:

• Lead analytical activities to support clinical and commercial biologics manufacturing, ensuring testing readiness throughout technology transfer and commercial production.
• Serve as the analytical subject matter expert (SME) for biologics products, providing scientific support for analytical testing.
• Manage analytical method lifecycle activities, including method transfer, qualification and validation.
• Collaborate with QC and clients to ensure successful method implementation in the QC laboratory.
• Develop and/or optimize new analytical test methods, support method troubleshooting and resolve analytical issues related to chromatography, electrophoresis, spectroscopic methods, bioassays, and general physicochemical characterization techniques.
• Author and review technical reports, protocols, validation documents and method transfer packages.
• Analyze and trend analytical data to identify process or product quality risks and recommend appropriate mitigation actions.
• Participate in regulatory inspections, customer audits, and internal audits as the analytical science representative, addressing technical questions and commitments.
• Drive innovation and continuous improvement initiatives by evaluating new analytical technologies, automation opportunities, and industry best practices to enhance laboratory efficiency and product understanding.

Preferred Qualifications

• Bachelor's, Master's, or PhD in Biochemistry, Biotechnology, Analytical Chemistry, Pharmaceutical Sciences, or related scientific discipline.
• Experience in GMP biologics manufacturing, including monoclonal antibodies (mAbs), recombinant proteins, vaccines, or advanced therapy medicinal products (ATMPs).
• Hands-on knowledge of analytical techniques such as HPLC/UPLC, SEC, IEX, CE-SDS, cIEF, ELISA, PCR, UV-Vis, and other biologics characterization methods.
• Strong understanding of ICH and GMP requirements related to analytical method validation and biologics product quality.
• Excellent technical writing, data interpretation and cross-functional collaboration skills.