Senior Scientist For analytical Science & Technology

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 120,000 - 170,000; Full time

Benefits offered by this job

International assignment to China site

Job summary

WUXI XDC Singapore Private Limited is seeking an Analytical Science & Technology Senior Scientist to lead analytical activities for clinical and commercial biologics manufacturing. You will act as the analytical SME, overseeing method transfer, qualification, validation, and collaboration with QC and clients to ensure successful implementations.

The role includes developing new analytical methods, troubleshooting chromatography, electrophoresis, spectroscopic techniques, and bioassays, with

Qualifications

• GMP biologics manufacturing experience required.
• Hands-on experience with HPLC/UPLC and other analytics.
• Strong scientific writing and cross-functional collaboration skills.

Responsibilities

• Lead analytical activities to support clinical and commercial biologics manufacturing, ensuring testing readiness throughout technology transfer and commercial production.
• Serve as the analytical 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 and troubleshoot analytical issues.
• Author and review technical reports, protocols, validation documents and method transfer packages.
• Analyze and trend analytical data to identify risks and propose mitigations.
• Support regulatory inspections, customer audits, and internal audits as the analytical representative.

Skills

GMP Biologics

Data interpretation

Cross-functional teamwork

Analytical thinking

Education

Bachelor/Master/PhD in Biochem/Analytical science

Tools

HPLC/UPLC

SEC

IEX

CE-SDS

cIEF

ELISA

PCR

Job description

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