Quality Control Operation Principal Scientist

WuXi Biologics; Singapore; On-site; SGD 60,000 - 110,000; Full time

Job summary

WuXi Biologics Singapore is seeking a senior Quality Control professional to lead GMP-compliant QC operations at the Tuas Biomedical Park site. You will draft sampling plans, manage stability studies, and review QC SOPs and documents while ensuring data integrity and regulatory alignment.

This role requires strong writing and communication skills, 6–8 years in QC, and proficiency with LIMS (CISpro) and MS Office.

Qualifications

• Bachelor of Science in Chemistry, Microbiology, Biochemistry or equivalent.
• 6–8 years of relevant QC experience in a GMP/biopharma environment.
• Strong scientific writing and documentation skills.
• Experience with stability studies and ICH guidelines is preferred.

Responsibilities

• Oversee daily QC operations to ensure GMP compliance and data reliability.
• Manage QC sample, stability, and retain sample workflows including storage and disposal.
• Draft sampling plans, stability protocols, and QC documents.
• Develop and review SOPs, method validation, and assay documentation.
• Support LIMS and Cispro activities for sample tracking.
• Participate in internal and regulatory audits and client inspections.
• Assist in technology transfer and address QC-related deviations.

Skills

QC Operations

GMP Compliance

Analytical Writing

Data Interpretation

Communication Skills

Problem-Solving

Education

Bachelor of Science in Chemistry/Biochemistry/Microbiology

Advanced Degree (optional)

Tools

LIMS (CISpro)

MS Office (Word/Excel/PowerPoint)

Job description

WuXi Biologics is a leading global Contract Research Development and Manufacturing Organization (CRDMO) specializing in biologics. The Singapore site is a greenfield biopharmaceutical start-up project with large-scale Drug Substance (DS) and Drug Product (DP) manufacturing operations, establishing one of the largest biologics production capacities in Singapore.

The Quality function is responsible for ensuring that all products meet regulatory requirements, internal quality standards, and patient safety expectations. The team performs laboratory testing and quality assessments throughout the manufacturing process to verify product quality and compliance.

Working Location : Tuas Biomedical Park. Company shuttle bus is provided at various MRT pick-up locations

Job Responsibility

• Responsible for QC daily operation and management to comply with GMP, data reliability and occupational safety protection requirements.
• Responsible for QC sample, stability and retain sample management, including but not limited to receiving, storage, aliquoting, distributing, tracking and disposing of QC testing sample and reference standards.
• Responsible for drafting sampling plan, stability protocol and report.
• Responsible for drafting QC department documents, quality standards, analytical method SOPs and application materials, as well as review of relevant documents from other departments involving QC.
• Take up LIMS and Cispro specialist roles to support sample, reference standards, retain and stability sample management.
• Participate in drafting department OPS management and changes in related analytical methods, may participate in LIR (lab investigation), or lab OOS, and reviewing changes and deviations in other departments involving QC.
• Provide laboratory support guidance in any related investigation of production deviations and assist in solving quality problems that arise during technology transfer and daily production (when required).
• Ensure that laboratory reagents, consumables and related test solutions are managed and stocked sufficiently (without impacting testing TAT) as required.
• Participate in clients’ audits, regulatory audits and internal and external inspections. Ensure department compliance metrics are well controlled to adhere to the QA Quality council and Quality Management review metrics.
• Execute budget planning directions in terms of CAPEX and OPEX expenditure for the department as part of company-wide cost control policy.
• Any other duties assigned by the supervisor (when applicable).

Other requirements

• Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
• 6 - 8 years of relevant experience Quality Control or related field or equivalent experience.
• Strong communication skills, both written and verbal, and outstanding interpersonal skills.
• Strong skills in scientific and technical writing.
• Good software operation skill, intermediate to advanced level in Microsoft Word, Excel, PowerPoint.
• Critical thinking, scientific reasoning and problem-solving skills.
• Experience in quality control laboratory or in a GMP environment.
• Experience setting ICH based stability studies for therapeutic proteins.
• Familiar with statistical tools for stability data interpretation and setting expiration date based on stability data and guidance.
• Ability to use judgment as dictated by complexity of situations.
• Ability to work in a team environment and independently as required