Senior Process Development Engineer 2, MSAT
Singapore, Tuas Singapore
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there is no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
As a senior process development engineer, you will part of a team that leads the technology transfer of new processes into Lonza Singapore production facility, provide process support & monitoring and perform process investigations to ensure process robustness.
- Technology Transfer: Lead the timely and successful transfer of the Cell Culture or Purification stages of the customer’s manufacturing process(es) into the Lonza Singapore production facility. Work with other MSAT team members, technical experts from Lonza’s customer companies and with Lonza Manufacturing (MFG), Quality Assurance (QA), Quality Control (QC), and other departments on the technology transfer.
- Process Support: Lead the preparation, execution and post-campaign activities for Cell Culture or Purification stages of the customer’s manufacturing processes at Lonza Singapore production facility. Become proficient with all processes in the facility and develop ability to support/lead activities for multiple cell lines. Monitor processes on a regular basis to develop understanding of process behavior and prospectively identify process issues. Develop ability to generalize issues across cell lines.
- Write change requests and drive to implementation as needed.
- Review Cell Culture or Purification process manufacturing batch records and provide supervision to Manufacturing technical document writing specialists on cell line specific aspects of batch records.
- Lead the investigation into process trends to support process monitoring requirements, support preparation of APR and CPV reports, perform work-stages to support customer BLA filing
- Support production runs and perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues for Cell Culture or Purification operations.
- Actively engage customer technical experts as necessary to progress technology transfer or process support activities.
- Perform/support experiments in the MSAT small-scale process lab to support process technology transfer or investigations. Follow all applicable lab safety policies.
- Support inspections and audits by customer and regulatory authorities as required.
- Any other duties as assigned by your Supervisor/Manager.
- Degree in Chemical Engineering, Chemistry or a related discipline.
- Extensive experience in Biotechnology process development, process support, research or a related manufacturing environment.
- Prior hands-on experience in cell culture or protein purification experimental technique and equipment.
- Knowledge of Excel as well as Statistical Data Analysis tools.
- Excellent communication skills, outstanding action orientation, and ability to work well in a cross-functional technical environment.
- Excellent technical writing skills, ability to provide attention to detail is essential.
- Demonstrated track record in completing projects under tight timelines.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.