AST & QC Specialist
19 hours ago
singapore, singapore
Hilleman Labs
Full-time
US$60,000 - US$80,000 Contract
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Join our mission to advance biologics and vaccine development As an AnalyticalScience & QC Specialist with a focus on Cell Biology and/or In-Process Control(IPC), you'll play a critical role in ensuring product quality, compliance, and innovation during Drug Substance (DS) and Drug Product (DP) manufacturing. This position supports day-to-day laboratory operations, analytical method transfers, datatrending, and quality investigations in a dynamic, collaborative environment aligned with GMP standards and Hilleman-laboratories Quality Policies. Support biologics and vaccine development through analytical science and quality control. Ensure product quality and compliance in a dynamic, collaborative environment. Focus on generating critical data and advancing vaccine development. Responsibilities:
General
Maintain high standards of lab operations
including housekeeping, equipment maintenance, inventory management, and autoclaving to ensure smooth workflows. Develop, review, and update QC and Analytical Sciences (IPC) SOPs
for both GMP and non-GMP testing environments. Perform accurate testing, documentation, and timely reporting
in compliance with cGMP and non-GMP standards to support manufacturing and product release. Train and mentor analysts
on testing methods and SOPs; lead projects such as equipment qualification, method validation, and process improvements. Troubleshoot and resolve analytical equipment and testing issues
promptly to maintain operational efficiency. Investigate quality incidents and lab deviations, lead Root Cause Analysis (RCA),
and implement corrective and preventive actions (CAPA). Collaborate with cross-functional teams
and act as a liaison for tech
General
Maintain high standards of lab operations
including housekeeping, equipment maintenance, inventory management, and autoclaving to ensure smooth workflows. Develop, review, and update QC and Analytical Sciences (IPC) SOPs
for both GMP and non-GMP testing environments. Perform accurate testing, documentation, and timely reporting
in compliance with cGMP and non-GMP standards to support manufacturing and product release. Train and mentor analysts
on testing methods and SOPs; lead projects such as equipment qualification, method validation, and process improvements. Troubleshoot and resolve analytical equipment and testing issues
promptly to maintain operational efficiency. Investigate quality incidents and lab deviations, lead Root Cause Analysis (RCA),
and implement corrective and preventive actions (CAPA). Collaborate with cross-functional teams
and act as a liaison for tech