QC Operations Lead, Principal Scientist/Manager (Biologics)

WuXi Biologics; Singapore; On-site; SGD 67,000 - 100,000; Full time

Job summary

WuXi Biologics Singapore is seeking an experienced QC professional to lead daily QC operations in a GMP environment for biologics manufacturing. You will ensure data reliability, manage samples, and uphold safety and quality standards on the production floor.

Responsibilities include drafting sampling plans, stability protocols and reports; reviewing QC documents and SOPs; supporting LIMS and Cispro roles; and assisting audits and investigations.

Qualifications

• Bachelor of Science degree in Chemistry, Microbiology, Biochemistry or equivalent.
• 6–8 years of relevant experience in Quality Control or related field.
• Strong written and verbal communication and interpersonal skills.
• Proficient with MS Word, Excel, PowerPoint.
• Experience in GMP environments and ICH-based stability studies.
• Familiar with statistics for stability data interpretation.
• Ability to work in a team and independently.

Responsibilities

• QC daily operation and management compliant with GMP and safety.
• Manage QC samples, stability and retain samples including receiving, storage, aliquoting, distributing, tracking, disposing.
• Draft sampling plans, stability protocols and reports.
• Draft QC department documents and SOPs, review related documents.
• Support LIMS and Cispro roles for sample and reference management.
• Participate in department OPS changes, LIR, OOS reviews in QC.
• Provide lab support guidance for investigations of deviations.
• Ensure reagents and consumables stocked, maintain testing TAT.
• Participate in client, regulatory, internal inspections; ensure QA metrics.
• Assist budgeting for CAPEX/OPEX within department.

Skills

Quality Control

Communication skills

Scientific writing

MS Word

MS Excel

MS PowerPoint

GMP experience

Stability studies

Education

Bachelor of Science degree

Advanced degree in Chemistry/Microbiology/Biochemistry

Tools

LIMS

Cispro

Statistical tools

Job description

WuXi Biologics Singapore is seeking an experienced QC professional to lead daily QC operations in a GMP environment for biologics manufacturing. You will ensure data reliability, manage samples, and uphold safety and quality standards on the production floor.

Responsibilities include drafting sampling plans, stability protocols and reports; reviewing QC documents and SOPs; supporting LIMS and Cispro roles; and assisting audits and investigations.