Senior Analyst, Quality Control (Cell & Gene Therapy)
Location: Singapore
About the Role
We are seeking a Senior Analyst, QC (CGT) to support quality control testing for cell and gene therapy products. This role requires hands-on expertise in bioassays and environmental monitoring, supporting testing of environmental, in-process, and final product samples in a cGMP-regulated environment. The successful candidate will play a key role in ensuring product quality, compliance, and operational excellence.
Key Responsibilities
- Perform and prioritize QC testing to meet business and production timelines.
- Execute testing of final product, in-process, raw material, and environmental samples in accordance with SOPs and test methods.
- Conduct QC assays including total particulates, air and surface viable monitoring, cell counts, flow cytometry, sterility testing, and ELISA.
- Track, review, and manage external testing (e.g., sterility, virus, mycoplasma).
- Document, review, and maintain results in compliance with cGMP and data integrity requirements.
- Provide general laboratory support including equipment maintenance, inventory management, autoclaving, and housekeeping.
- Support sample logistics, retention sample storage, QC document control, and shipment coordination.
- Prepare and maintain standards and reagents in line with GMP requirements.
- Troubleshoot analytical methods and laboratory equipment issues.
- Participate in equipment qualification, maintenance, and validation activities.
- Lead and support OOS and deviation investigations, including report drafting.
- Support method transfers, method validation, and assay trend analysis.
- Author and revise SOPs, test methods, and change controls.
- Act as a trainer for QC test methods and support junior team members.
- Contribute to departmental KPIs and continuous improvement initiatives.
Qualifications
- Degree or Diploma in Chemistry, Life Sciences, or a related scientific discipline.
- Relevant QC testing experience in a regulated pharmaceutical, biotech, or CGT environment.
- Strong working knowledge of cGMP regulations.
- Experience with bioassays, environmental monitoring, and QC laboratory operations.
- Proven problem-solving and analytical skills.
- Strong communication skills and ability to work effectively in a team environment.
Why This Role
This is an opportunity to work at the forefront of cell and gene therapy, contributing directly to the manufacture of innovative therapies that improve patient liveswithin a collaborative, ethical, and performance-driven environment.
