Key Responsibilities

• Supervise a team of manufacturing staff and is responsible for compliance status of the GMP
  facility operations.
• 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.

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Other Responsibilities

• 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.

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Education

• Minimally requires a Bachelor’s degree in Pharmaceutical Engineering, Bioengineering or Life
  Science related field.

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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.