About the Role
We are seeking two highly skilled Tech Transfer Leads / MSAT Engineers to serve as the vital technical bridge between our Process Development (R&D) and large-scale commercial manufacturing operations. In this role, you will be responsible for translating complex laboratory-scale processes into robust, high-yield commercial manufacturing runs. You will play a pivotal role in ensuring our facility is ready for the next generation of life-saving products.
Key Responsibilities
- Technology Transfer: Facilitate the seamless transfer of manufacturing processes from development sites to the commercial floor, ensuring all technical requirements are met.
- Process Scale-Up: Lead the scale-up of upstream and/or downstream processes, optimizing for consistency and efficiency in a large-scale environment.
- Process Monitoring: Spearhead technical monitoring and oversight during Engineering Runs to ensure real-time troubleshooting and process adherence.
- Data Analysis: Identify and analyze process variability and data trends. Use statistical tools to maintain process control and drive continuous improvement.
- Optimization: Continuously evaluate and optimize the performance of existing manufacturing processes to improve yields and reduce deviations.
Key Deliverables
In this role, your performance will be measured by the successful delivery of:
- Tech Transfer Documentation: Comprehensive transfer protocols, reports, and master batch record inputs.
- Process Performance Reports: Detailed summaries of Engineering and Validation runs.
- Monitoring Dashboards: Real-time process monitoring tools to track Critical Process Parameters (CPPs).
- Process Capability Analyses: Statistical evaluations (Cp/Cpk) to prove long-term process stability.
Required Skills & Qualifications
- Education: Bachelor’s or Master’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related technical field.
- Technical Expertise: Strong fundamental knowledge of Upstream (cell culture, bioreactors) or Downstream (purification, chromatography, filtration) bioprocessing.
- Industry Experience: Proven experience in Technology Transfer and Process Scale-up within a biopharmaceutical or vaccine environment.
- GMP Knowledge: Hands-on experience working on a GMP manufacturing floor, with a deep understanding of compliance and cleanroom operations.
- Analytical Skills: Proficiency in statistical analysis software and data visualization tools to interpret complex biological data sets.
Work location : SINGAPORE
Pay: RM21,000.00 - RM30,000.00 per month
Work Location: In person