QC Manager & Senior Scientist

WuXi Biologics; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading biologics service provider in Singapore is seeking a Quality Control professional to ensure compliance with GMP during testing activities. This role requires 4 years of relevant experience, with a strong emphasis on Quality Control standards and documentation practices. The ideal candidate will manage raw material testing, oversee laboratory functions, and must possess a Bachelor's degree in a scientific field. Opportunities for professional growth in a dynamic environment await you!

Qualifications

• 4+ years of relevant experience in Quality Control or a related GMP-regulated environment.
• Strong understanding of GMP requirements and QC SOPs.
• Able to communicate effectively technical and scientific data.

Responsibilities

• Ensure compliance with GMP requirements and controlled documentation.
• Perform raw material testing activities in accordance with cGMP.
• Prepare, review, and approve analytical methods and training materials.

Skills

Quality Control testing

GMP compliance

Data analysis

Troubleshooting laboratory issues

SOP drafting

Education

Bachelor's degree in Chemistry, Microbiology, Biochemistry, or related

Job description

Overview

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the worlds top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.

Job Responsibilities

• Ensure understanding of GMP requirements and compliance with controlled documentation.
• Perform and oversee raw material and compendial testing activities in accordance with cGMP and internal SOPs.
• Receive samples, execute testing, conduct plate reading and transfers, and ensure accurate and timely reporting of results.
• Support or perform raw material sampling activities when required.
• Manage raw material and sample‑related areas, including sampling rooms, sample storage rooms, and regulatory retain sample rooms, ensuring controlled processes and compliant storage conditions.
• Oversee reagent and consumable inventory management to support uninterrupted QC RM/Compendial operations.
• Ensure laboratory data integrity through compliance with GDP practices and data governance requirements.
• Ensure compliance with training, laboratory preparation, documentation, and general laboratory maintenance standards.
• Prepare, review, and approve SOPs, analytical methods, training materials, and provide technical training and coaching to junior staff.
• Drive method optimization initiatives to improve efficiency while maintaining Quality Control standards.
• Troubleshoot assay, instrument, and reagent‑related issues and implement corrective actions as needed.
• Prepare, review, or execute validation and qualification documents supporting new materials, process changes, and laboratory systems.
• Lead and conduct investigations for OOS/OOT/atypical results, perform root cause analysis, and define and implement CAPAs.
• Attend and contribute to internal and external meetings; present data summaries, investigation outcomes, and trending analyses to project teams or clients.
• Actively support internal, client, and regulatory audits, including defending methodologies and laboratory practices to auditors.
• Participate as functional lead or subject matter expert in early‑phase project discussions to support QC methodology development with PM, CMC, and project teams.
• Perform additional duties as assigned by the supervisor.

Requirement:

• Bachelor’s degree or above in Chemistry, Microbiology, Biochemistry, or a related scientific discipline.
• 4 years and above of relevant experience in Quality Control or a related GMP‑regulated environment with prior people or technical leadership experience is required.
• Extensive hands‑on experience in Quality Control testing.
• Ability to independently generate and review protocols, reports, and GMP documentation.
• Strong understanding of GMP requirements and compliance with QC SOPs.
• Ability to draft and review SOPs and analytical method procedures (AMPs).
• Proficiency in documenting and reviewing laboratory data in accordance with GDP and ALCOA+++ principles.
• Ability to independently perform data analysis and review results.
• Capable of troubleshooting routine laboratory, assay, and equipment issues.
• Experience in initiating and owning quality events, including laboratory investigations and deviations.
• Strong time management skills with the ability to manage multiple priorities and meet defined timelines.
• Ability to recommend improvements and optimizations to analytical methods and sampling plans.
• Ability to balance strategic planning with hands‑on execution to support departmental and site objectives.
• Able to interpret technical and scientific data effectively.
• Willingness to support weekend and shift work as operationally required.
• Able to promptly escalate issues and collaborate with supervisors to resolve uncertainties.

APPLY NOW

As we extend our global reach, we are looking for talent interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential.

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.