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Manager of Manufacturing Operations
- Supervise a team of manufacturing staff and is responsible for compliance status of the GMP
- Lead the start-up and development of GMP and GDocP procedures.
- Provide technical leadership and support to the manufacturing team in process validation
activities to ensure clinical manufacturing readiness.
- Ensure manufacturing schedule is maintained to meet clinical trials timelines.
- Develop, revise, and reviews SOPs, logbooks, and Manufacturing Batch Records (MBR) to
ensure compliance to GDocP (ALCOA principle) standards.
- Work cross functionally with Quality, Regulatory/CMC and Supply Chain to drive the
preparation for GMP facility audit.
- Participate in cross-functional discussions for the implementation of improvement projects.
- Support the development of QMS.
- Oversee technology transfer activities of manufacturing process to other manufacturing sites
overseas and with CMOs.
- Assess, review, and communicate staff performance and motivate and drive teamwork.
- Manage project timelines, resources, and deliverables through cross-functional collaboration.
- Ensure accurate reporting of production material usage.
- Accountable for all cleanroom activities and operations.
- Ensure executed procedures are compliant to SOPs.
- Pro-active in ensuring site safety and quality standards are adhered to.
- Review and approve MBR for its correctness and completeness.
- Perform investigation for manufacturing non-conformances and implements CAPAs
- When needed, support manufacturing team in implementing change controls.
- Minimally requires a Bachelor’s degree in Pharmaceutical Engineering, Bioengineering or Life
Science related field.
Skills and Requirements
- Minimally 5 years of GMP experience in the biotechnology or life science related field.
- Good knowledge of cGMP and GDP relevant to the biotechnology industry.
- Direct experience in Cell Therapy related field highly preferable.
- Knowledge of international CMC regulatory requirements towards qualification and validation of
processes, reagents and devices for clinical application.
- Ability to prioritise, plan and manage deliverables effectively.
- Strong leadership and people management skills.
- Display good level of problem-solving ability.
- Good project management skills.
- Good interpersonal and organization skills with attention to detail.
- Effective written and oral communication.