Senior Process Development Engineer 1/2 (MSAT), Cell Therapy
Tuas Singapore, 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.
The role will lead process and technology transfer from our customers’ site into Lonza Singapore Cell Therapy facility. Role will perform process support in troubleshooting and deviation investigation of product impact justifications.
- Lead/ Support the timely and successful transfer of customer’s manufacturing process into the Lonza Bioscience Singapore production facility.
- Work with other MSAT team members, technical experts from Lonza’s customer companies and work with:
- Manufacturing team on training and resource planning for execution of pilot runs/engineering runs/study runs.
- Supply Chain Management team on reviewing material package for raw materials requirements and bill of materials (BOM) setup.
- Project Management team on project deliverables and customer communications.
- Quality Assurance (QA) team on regulatory and compliance requirements of the manufacturing process.
- Quality Control (QC) team on developing sampling plan.
- Validation team on equipment validation for new customer/product introduction into the facility.
- Perform analysis and design of process fit and process-scale up in collaboration with vendors, customer technical experts or Lonza’s Process Development and MSAT teams of other sites.
- Design and perform experiments on scale down process in MSAT lab to support process technology transfer. Follow all applicable lab safety policies.
- Author, review and/ or approves of process-related documents i.e. Process overview, APS protocols, development/ investigative protocols and reports.
- Develop and define training programs and requirements to facilitate integration of new manufacturing process into Lonza Bioscience Singapore production facility.
- Interact with customer technical experts as necessary to progress technology transfer
- Performs technical review/ approvals of batch records, process SOPs, deviations, change controls, training documents, protocols, development/ investigative reports, CAPAs.
- Support investigations into process issues/ deviations and if required, coordination of the associated troubleshooting activities and/or perform experiments in the MSAT small-scale cell culture process lab. Follow all applicable lab safety policies.
- Manage change control implementation for process changes that are driven by process changes/ improvements and coordination of non-GMP and/or non-clinical runs.
- Lead/ support pre-campaign preparation activities.
- Oversight on the production floor to provide support and review of operations. Escalate issues to management appropriately and interface with customer on issue resolution.
- Oversight of on-going trainings to ensure alignment between training and process requirements.
- Monitor manufacturing run process data and monitor for run-to-run consistency.
- Identify and drive implementation of process improvements as required.
- Support inspections and audits by customer and regulatory authorities as required.
- Support plant start-up and pilot/clinical/commercial run. Perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues in operations, and participate in the generation and assessment of required change controls.
- Able to recognize abnormalities and/or potential event that might affect process, product quality and/or safety & escalate promptly to the appropriate level for attention.
- Able to apply problem-solving tools such as 5Whys, 5M, fishbone diagrams to identify root causes.
- Any other duties assigned by the Manager.
- Degree in Chemical Engineering, Biotechnology, Chemistry or a related discipline.
- Significant years of experience in Biotechnology process development, process support, research or a related manufacturing environment is advantageous. Experience in cell therapy is preferred.
- Prior hands-on experience in adherent, human cell culture experimental technique and equipment.
- Knowledge of Excel as well as Statistical Data Analysis tools.
- Experience in using TrackWise to perform change control, effectiveness check, corrective actions and preventive actions (CAPAs) is highly desirable.
- Experience in troubleshooting processing related issues and/or equipment is desirable.
- Knowledge of Operational Excellence tools and concepts such as Lean manufacturing and Six Sigma.
- Excellent communication skills, outstanding action orientation, and ability to work well in a fast pace, cross-functional technical environment.
- Analytical with good technical writing skills.
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.