Lead Engineer, MSAT Purification

4 weeks ago

Singapur, Singapore Lonza Full time

Responsibilities

  • 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 or equivalent experience), 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 further understand process behavior and prospectively identify process issues. Develop the ability to generalize issues across processes. 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, perform technical investigations, and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues for cell culture.
  • 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 customers and regulatory authorities. Provide technical mentorship and share process knowledge with MSAT team members and other departments. Uphold data integrity principles in accordance with Lonza policies. Proactively evaluate, identify, and improve the data integrity process. Any other duties as assigned by your Supervisor/Manager.
What We Are Looking For
  • Over 5+ years of experience in biotechnology process development, process support, research, or a related manufacturing environment.
  • Graduate degree in Chemical engineering, biochemical engineering, biochemistry/chemistry/biological science, or a related field.
  • Prior experience in technology transfer in the purification or cell culture domain.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

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