Senior Process Engineer, MSAT

1 month ago

Emory, United States LONZA BIOLOGICS TUAS PTE. LTD. Full time

Roles & Responsibilities 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, 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 also lead investigations into process trends, issues, or deviations.

Key Responsibilities:

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 or Lonza donor sites, Manufacturing (MFG), Quality Assurance (QA), Quality Control (QC), and other departments on the technology transfer.

Process Support:

Lead the preparation, execution, process monitoring, 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 the ability to support/lead activities across multiple processes.

Monitor processes on a regular basis to have a further understanding of process behavior and prospectively identify process issues.

Develop the ability to generalize issues across processes.

Write change requests and drive to implementation as needed.

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.

Support plant start-up and pilot/commercial runs and perform technical investigations and help author technical reports to support the close-out of deviations, trouble-shoot process excursions/issues for cell culture or purification operations.

Design and perform/support small-scale experiments/studies in the 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 in chemical engineering, biochemical engineering, biochemistry/chemistry/microbiology, or related discipline. Extensive work experience in Biotechnology process development, process support, research, or a related manufacturing environment. Prior hands-on experience in 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.

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.

Skills: Biochemistry, cGMP Manufacturing, Data Analysis, Technology Transfer, Manufacturing Processes, GMP, Cell Culture, Biologics, Purification, Manufacturing Operations, Process Manufacturing, Life Sciences, Chemical Engineering

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