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Key Responsibilities:
- Set up production project plan and schedule for Commercial DS Asset.
- Lead the Manufacturing Support Team including but not limited to media and buffer preparation, assembly, sterilization, material management, GMP documentation, investigations, CAPA, shop floor tour, to meet the quality, delivery and cost objectives of assigned customer projects
- Host the PIP as the point contact.
- Manage equipment purchase and operation readiness, coordinate with Engineering Department for spares, PM schedule and related matters.
- Set project priority and delivery timeline for projects with Project Management team.
- Participate in New Production Introduction, Tech Transfer and Risk Assessment and be responsible for checking the production technology and operation risks of projects to ensure the successful completion of production.
- Work with Engineering Department to ensure availability of facility, utility and equipment
- Establish a culture of EHS and GMP compliance through training, SOPs, walkaround
- Ensure effective communication of site directions to team and provide feedback from team to Asset Leadership Team.
- Institute a culture of continuous improvement such as lesson learnt, best practice sharing to enhance the quality, efficiency, operating cost of assets.
- Work collaboratively with peers in other sites / Assets to share and implement best practices
- Attract, develop and retain the team. Develop a robust succession pipeline.
- Participate in clients and authority inspections and any follow-up actions.
- Manage operating expense and others to meet the Financial KPIs.
- During Project stage of Singapore Site, collaborate with Production teams in Reference Site to develop and approve design input and URS for packages under the ownership of Asset, and to establish team for compliant and efficient start-up and operations for Asset.
Requirements:
- Bachelor degree in Chemical Engineering, Biotechnology, Pharmacy. PhD, Master’s or MBA is highly regarded.
- At least 10 years in Production role (6 years for PhD holders) and 5 years in leadership position in a cGMP pharmaceutical plant or equivalent.
- Personnel management and project management skills
- Leadership, teambuilding, and mentoring / coaching skills
- Critical thinking and problem-solving skills
- Expert-level knowledge of pharmaceutical technology and processes
- Good English reading and writing ability, equivalent ability in Chinese is highly preferred.
Key Responsibilities:
- Set up production project plan and schedule for Commercial DS Asset.
- Lead the Manufacturing Support Team including but not limited to media and buffer preparation, assembly, sterilization, material management, GMP documentation, investigations, CAPA, shop floor tour, to meet the quality, delivery and cost objectives of assigned customer projects
- Host the PIP as the point contact.
- Manage equipment purchase and operation readiness, coordinate with Engineering Department for spares, PM schedule and related matters.
- Set project priority and delivery timeline for projects with Project Management team.
- Participate in New Production Introduction, Tech Transfer and Risk Assessment and be responsible for checking the production technology and operation risks of projects to ensure the successful completion of production.
- Work with Engineering Department to ensure availability of facility, utility and equipment
- Establish a culture of EHS and GMP compliance through training, SOPs, walkaround
- Ensure effective communication of site directions to team and provide feedback from team to Asset Leadership Team.
- Institute a culture of continuous improvement such as lesson learnt, best practice sharing to enhance the quality, efficiency, operating cost of assets.
- Work collaboratively with peers in other sites / Assets to share and implement best practices
- Attract, develop and retain the team. Develop a robust succession pipeline.
- Participate in clients and authority inspections and any follow-up actions.
- Manage operating expense and others to meet the Financial KPIs.
- During Project stage of Singapore Site, collaborate with Production teams in Reference Site to develop and approve design input and URS for packages under the ownership of Asset, and to establish team for compliant and efficient start-up and operations for Asset.
Requirements:
- Bachelor degree in Chemical Engineering, Biotechnology, Pharmacy. PhD, Master’s or MBA is highly regarded.
- At least 10 years in Production role (6 years for PhD holders) and 5 years in leadership position in a cGMP pharmaceutical plant or equivalent.
- Personnel management and project management skills
- Leadership, teambuilding, and mentoring / coaching skills
- Critical thinking and problem-solving skills
- Expert-level knowledge of pharmaceutical technology and processes
- Good English reading and writing ability, equivalent ability in Chinese is highly preferred.