Senior Process Engineer MSAT

2 days ago

Singapur, Singapore Lonza Full time
Join Our Team as a Senior Process Engineer MSAT

Lonza is a global leader in life sciences, operating across three continents. Our success is built on the talent and dedication of our people, who work together to devise innovative solutions that help businesses improve people's lives.

We're proud to be the 1st biologics contract manufacturer in our region, offering exposure to upcoming biotech and established pharmaceutical companies, as well as the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow.

Key Responsibilities:
  • Lead investigations into process trends, issues, or deviations involving multiple departments and customers.
  • Write change requests and drive 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.
  • 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 cell culture or purification operations.
  • Design and perform/small-scale experiments/studies in lab to support technology transfer or investigations, following 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.
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.

We're committed to respecting and protecting our people and our environment. Our success is built on the satisfaction that comes with improving lives all around the world, and the satisfaction that comes with making a meaningful difference.

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