Senior Scientist For Analytical Science & Technology
About the role Analytical Science & Technology (AST) Senior Scientist role supporting clinical and commercial biologics manufacturing. Lead analytical activities to ensure testing readiness throughout technology transfer and commercial production, serving as the analytical subject matter expert (SME) for biologics products. Key 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
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
About you 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