Senior/Lead Process Engineer (DSP), 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.
Lonza is establishing a strategic bio- manufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market. You will support the technical transfer of manufacturing processes (Downstream) using a defined structured approach between Process Development, through pilot stage to current Good Manufacturing Practice manufacturing. The role will be to provide technical support via project teams to develop the required technical process documentation in collaboration with external customers as well as other cross-functional team members to provide oversight through to a robust capable current Good Manufacturing Practice scale process.
- Attends global network meetings as assigned
- Complete project related tasks to support various stages of work per project timeline.
- Maintain and optimise process transfer tools and templates such as process modelling, gap analysis, ECA list, PFD, RML, bioburden risk assessment, base data, core BOM and relevant SOPs.
- Lead root cause assessment (RCA) for critical and major (on case by case basis) deviations
- Actively identifying, escalate and propose imitigation for project, operations and process risks to Project science, Process Engineering and MSAT management team.
- Support/own/assess operations and process improvements, cost savings and new innovation related projects, change requests and CAPAs
- Lead automation and controls process design
- Lead/ Support network initiatives such as SUA Design, E&L study coordination, MCC assessments, etc.
- Design and lead additional studies (e.g. kLa, mixing, water runs)
- Lead/Support late Stage and commercial manufacturing activities and preparation
- Provide quality support such as Risk Assessments, Audit Observations, GROUP policy reviews and Vendor Change Notification assessments
- Generate/review “MSAT Academy” training materials
- Lead/Support technology transfer of manufacturing processes and MSAT representative in IPT/JPTs, for assigned projects.
- Provide technical guidance/mentorship for junior scientist in the area of expertise.
- Any other tasks as assigned by the supervisor or MSAT management team
- Bachelor/Master in Biological science or biochemical engineering disciplines
- Has knowledge in Downstream Operations, gained through on the job experience in either from laboratory process development or a manufacturing operations back ground
- Significant biotech industry experience/ Doctor of Philosophy in process development and process scale up manufacturing
- Has experience in Downstream operations preferably in a current Good Manufacturing Practice environment
- Good interpersonal skills with ability to work cross functionally both with internal and external customers. Experience in working in cross functional project management and technical transfer activities
- Proven problem solver and multi -tasking individual with track record of implementing improvements, has a good technical attention to detail, communication skills both written and verbal, interpersonal qualities with a continuous improvement positive mind set.
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 achieved 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.