Senior Manager* Manufacturing Support
This role is responsible in providing support to manufacturing operations of drug substance (DS) and drug product and ensures that the manufacturing team meets the safety, quality and product supply objectives with efficient and agile shopfloor operations. Your main responsibilities are:
- Collaborate with all functions within the site, more specifically with MS&T and engineering team during the project phase to ensure that the new transferred process is implemented successfully in the facility.
- Define and setup the structure of the team for the following scope:Manage / drive change control and deviations from manufacturing operations team.
Develop site contamination control strategy (CCS) with QA, and drives relevant CCS tasks related to DS/ Drug Product shopfloor operations.
Develop / review MES recipes for DS/ Drug Product shopfloor operations.
Develop / maintain SUT used in manufacturing operations.
Drives / lead continuous improvement initiatives.
Business owner of process equipment.
Review / executes commissioning and qualification protocols of process equipment.
- Hire, Lead and develop staffs to be a high performing team. Establish regular feedback sessions on staff objectives, ensure training of staffs according to training plans and continue to develop team competencies.
- Ensure team’s readiness for the commissioning and qualification phase of project.
- Drives safety and quality culture of the team.
- Define and create SOPs related to the operations.
- Review / develop process automation recipes with engineering team.
- Develop / review SUT used in process equipment.
- Ensure proper life cycle management of SUTs.
- Authors, reviews and approves SOPs related to DS/Drug Product operations.
- Define and create the appropriate training matrix / plan for the team.
- Define targets for operations support team.
- Ensure minimal downtime of equipment in DS and Drug Product suites by optimizing maintenance and validation needs, or by proactively seeking the appropriate department to restore manufacturing activities when required.
- Ensure that process deviations and environmental monitoring excursions are minimised through system based root cause analysis and follow up with appropriate system based corrective / preventive actions.
- Drives the team to have continuous improvement initiatives.
- Ensure GMP inspection readiness of the team. Lead / participate actively in quality audits and inspections.
- Manage and mitigate key operational, contamination control, and other quality risks of DS/ Drug Product operations.
- Carry out duties as per assigned by Head of Department, Operations.
Requirements
- At least Bachelor’s Degree in Chemical Engineering, life sciences or equivalent field.
- ≥ 10 years of working experience in biotechnology manufacturing industry.
- ≥ 5 years of people management experience.
- Extensive knowledge in downstream manufacturing technology (process equipment, system automation, general risks involved and ways of managing it)
- Extensive knowledge of SUT (general risks involved, and ways of managing it)
- Good knowledge in upstream manufacturing technology.
- Good knowledge in digital tools used in manufacturing environment (MES, automation systems etc).
- Experiences with collaborations with global multidisciplinary functions involved in technology transfer and manufacturing
- Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
- High degree of conscientiousness and diligence
- Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
- Self-starter and learning capacity
- Sense of ownership and honesty (proactive handling of errors)
- Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment
- Expectation to be hands on, interactive and display practical leadership
- Good communication skills
- Fluent in written and verbal English
Reg No.: R2090579
EA License No.: 02C3423
Recruitment Consultant
Manpower Singapore
[email protected]
