This role is responsible in setting up the drug substance (DS) and drug product (DP) shopfloor manufacturing operations and ensures that the team meets the safety, quality and product supply objectives with efficient and agile shopfloor operations during project phase.
In routine phase, the role is responsible in executing shopfloor manufacturing activities based on site manufacturing plan.
Your main responsibilities:
- Perform commissioning and qualification tasks where required
- Review commissioning and qualification reports
- Author process equipment operations and other related manufacturing related SOPs
- Perform or participate in safety risk assessment of operational tasks
- Review /develop and provide operability feedback process automation recipes with engineering team
- Review and provide operability feedback on Single Use Technologies (SUT) used in process equipment
- Review /develop and provide operability feedback MES recipes that minimizes human error
- Prepare and execute process water and technical runs
- Prepare for the site’s GMP readiness prior to start of PPQ
- Complete all required training and qualifications to perform relevant manufacturing operations
- Execute SOP defined manufacturing operations within GMP manufacturing setting
- Perform general housekeeping of manufacturing shopfloor
- Ensure manufacturing area and equipment readiness for site’s product supply adherence
- Escalation of all safety or quality incident / observation promptly
- Trainer of manufacturing equipment
- Identify and lead continuous improvement initiatives
- Perform first line manufacturing equipment troubleshooting
- Perform relevant manufacturing tasks as assigned by Operations Manager
What you have to offer:
- Diploma / Bachelor’s Degree in Chemical Engineering, life sciences or equivalent field
- Good knowledge in downstream manufacturing technology (process equipment, system automation, general risks involved and ways of managing it)
- Familiarity or prior working experience of Single Use Technologies
- Good knowledge in digital tools used in manufacturing environment (MES, automation systems etc)
- 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 and presentation skills
Assigned position level (Biotechnologist or Senior Biotechnologist) will commensurate with relevant years of working experience in biotechnology manufacturing industry.
Please take note that this will be a 12 months contract role.
