Biologics QC Analytics Lead — 6-Month China Assignment

WuXi XDC; Singapore; Vor Ort; SGD 90.000 - 120.000; Vollzeit

Zusammenfassung

WuXi XDC in Singapore seeks an analytical scientist to lead activities for clinical and commercial biologics as part of a 6-month assignment at Wuxi, China, before returning to support Singapore operations.

You will be the analytical SME, manage method transfers and validations, and work with QC to implement methods in the QC lab. Strong GMP biologics knowledge and hands-on analytical skills are essential.

Qualifikationen

• 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 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.

Aufgaben

• 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, 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.

Kenntnisse

HPLC/UPLC

SEC

IEX

CE-SDS

cIEF

ELISA

PCR

UV-Vis

Data interpretation

Ausbildung

Biochemistry / Biotechnology / Analytical Chemistry / Pharmaceutical Sciences degree

Jobbeschreibung

WuXi XDC in Singapore seeks an analytical scientist to lead activities for clinical and commercial biologics as part of a 6-month assignment at Wuxi, China, before returning to support Singapore operations.

You will be the analytical SME, manage method transfers and validations, and work with QC to implement methods in the QC lab. Strong GMP biologics knowledge and hands-on analytical skills are essential.