Senior Scientist, Biologics Analytics & Method Innovation

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; Presencial; SGD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

International assignment to China site

Descripción de la vacante

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

Formación

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

Responsabilidades

• 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.

Conocimientos

GMP Biologics

Data interpretation

Cross-functional teamwork

Analytical thinking

Educación

Bachelor/Master/PhD in Biochem/Analytical science

Herramientas

HPLC/UPLC

SEC

IEX

CE-SDS

cIEF

ELISA

PCR

Descripción del empleo

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