About the role
AI summarisedSenior MSAT Product Owner role in Singapore leading technical stewardship for biologics manufacturing, driving process improvements, technology transfers, and regulatory compliance across GMP operations.
BiopharmaOnsite
Key Responsibilities
- Lead technical stewardship for assigned products during scale-up, commercial manufacture, and continuous improvement
- Investigate and resolve product and process issues, using root cause analysis and evidence-based recommendations
- Support technical transfers and start-ups by creating transfer packages, validating processes, and coaching receiving teams
- Partner with manufacturing, quality and regulatory colleagues to ensure compliance and to prepare technical documentation for change controls and deviations
- Drive process reliability and efficiency projects using data, risk assessments, and robust controls
Requirements
- Bachelor’s degree in chemical engineering, biochemical engineering, pharmaceutical sciences or related field
- Minimum 8 years’ experience in pharmaceutical biologics manufacturing, process development or MSAT
- Practical experience with technology transfer, process troubleshooting and deviation investigations
- Strong knowledge of GMP principles and experience working with quality systems
- Demonstrated ability to analyze data, lead root cause analysis and implement corrective actions
- Effective communicator with experience working in cross-functional teams and managing stakeholders
- Advanced degree (master’s or PhD) in a relevant discipline
- Experience with aseptic processing or vaccine manufacturing
- Familiarity with process validation, statistical tools and continuous improvement methods
- Hands-on experience in a multi-site or global network environment
- Experience preparing technical reports for regulatory submission
- Prior program leadership experience (matrix leadership)