Quality Control Operation Principal Scientist

About the role

WuXi Biologics is building a large‑scale biologics manufacturing hub in Singapore. The Quality Control Operation Principal Scientist will lead daily QC activities, ensure compliance with GMP standards, and support the launch of drug substance and drug product manufacturing.

Key responsibilities

• Manage QC operations to meet GMP, data reliability, and occupational safety requirements.
• Oversee sample, stability, and retain sample handling – receiving, storage, aliquoting, distribution, tracking and disposal.
• Draft sampling plans, stability protocols, reports and QC department SOPs, quality standards, and application materials.
• Act as LIMS and Cispro specialist, supporting reference standard and stability sample management.
• Participate in lab investigations (LIR, OOS), deviation reviews, and provide guidance during technology transfer and routine production.
• Maintain adequate inventory of reagents, consumables and test solutions to avoid testing delays.
• Support client, regulatory and internal audits, and ensure compliance metrics align with QA council expectations.
• Contribute to CAPEX and OPEX budgeting for the QC department.

Required profile

• Bachelor’s or advanced degree in Chemistry, Microbiology, Biochemistry or a related field.
• 6–8 years of experience in Quality Control or a comparable scientific environment.
• Excellent written and verbal communication with strong scientific‑technical writing ability.
• Proficiency in Microsoft Word, Excel and PowerPoint at an intermediate to advanced level.

Required skills

• LIMS (Laboratory Information Management System) operation.
• Cispro software expertise.
• GMP compliance knowledge.
• Sample and stability management.
• Analytical method development and SOP drafting.
• Microsoft Word, Excel, PowerPoint.

What we offer

• Opportunity to work in a state‑of‑the‑art biopharmaceutical facility.
• Company shuttle service from multiple MRT locations.
• Exposure to global client audits and regulatory inspections.