Senior Process Development Engineer 1, MSAT
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s 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 in Lonza’s Singapore Tuas location, you will part of a team that leads the technology transfer of the cell culture stages of new processes into Lonza Singapore production facility, provide process support and monitoring and perform process investigations to ensure process robustness.
- Technology Transfer: Lead the timely and successful transfer of the cell culture 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 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 further understanding of process behavior and prospectively identify process issues. Develop ability to generalize issues across cell lines.
- Process Monitoring: Lead investigations into process trends to support process monitoring requirements, author the technical sections of APR and CPV reports, design and lead work-stages to support customer BLA filing.
- Write change requests and drive to implementation as needed.
- Review cell culture process manufacturing batch records and provide supervision to Manufacturing technical document writing specialists on cell line specific aspects of batch records.
- Identify training needs and design and prepare a variety of training materials for MFG operators on cell culture process batch records. Work with MFG to update process records to enable robust manufacturing operations.
- Support plant start-up and pilot/commercial runs and perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues for 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.
- Keep current appropriate databases with MFG cell culture process data and analyze to monitor run to run consistency of operations.
- Support inspections and audits by customer and regulatory authorities as required.
- Any other duties as assigned by your Supervisor/Manager.
- Degree in Chemical Engineering, Biochemical Engineering, Biochemistry/ Chemistry/ Microbiology or related discipline.
- Significant years of experience in Biotechnology process development, process support, research or a related manufacturing environment.
- Prior hands-on experience in cell culture 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.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieve ethically.
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.