Senior Process Engineer MSAT (USP)

Senior Process Engineer MSAT (USP)

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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

As a Senior Process Engineer, Upstream Process, MSAT you will 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. You will lead the preparation, execution, process monitoring and post-campaign activities for cell culture or purification stages of the customer’s manufacturing processes and also lead investigations into process trends, issues or deviations.

Key Responsibilities:

• Lead investigations into process trends, issues or deviations involving multiple departments and customers.
• Write change requests and drive to implementation.
• Review cell culture or purification process manufacturing batch records and provide technical input to MFG technical document writing specialists.
• Identify training needs and provide training materials for MFG operators on cell culture or purification process batch records. Work with MFG to update process batch 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, troubleshoot process excursions/issues for cell culture or purification operations.
• Design and perform/support small-scale experiments/studies in lab to support technology transfer or investigations. Follow all applicable lab safety policies.
• Support preparation of Annual Product Review (APR) and Continued Process Verification (CPV) summary reports, perform work-stages to support customer BLA filing.
• Maintain process databases and monitor batch to batch consistency of operations.
• Support inspections and audits by customer and regulatory authorities.
• Provide technical guidance and share process knowledge to MSAT team members and other departments.
• Any other duties as assigned by your Supervisor/Manager.

Key Requirements:

• Degree/Masters in Biological Sciences, Biochemical/Chemistry/Microbiology or any related discipline.
• Minimum 5-10 years of experience in Biotech Industry experience in cell culture experimental technique and Purification in biotech industry. Good Manufacturing Practices, US/EU regulations, supervision.
• Demonstrates critical thinking skills in problem solving and decision making.
• Attention to detail and high level of accuracy.

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.