Senior Bioprocess Engineer
3 days ago
We are Lonza Bioscience Singapore PTE. LTD., a global leader in life sciences operating across three continents. Our success is built on talented people working together to devise innovative solutions that help businesses improve lives around the world.
About the Role
This Senior Bioprocess Engineer will lead process/technology transfer into our Cell Therapy facility, ensuring seamless integration of customer manufacturing processes. You will work closely with cross-functional teams to troubleshoot and resolve product impact justifications, driving process improvements and excellence throughout the production process.
Key Responsibilities:
- Lead/support timely and successful transfer of customer manufacturing processes into our facility.
- Collaborate with MSAT team members, technical experts from customer companies, and manufacturing teams on training, resource planning, and execution of pilot runs/engineering runs/study runs.
- Work with Supply Chain Management team on reviewing material packages for raw materials requirements and BOM setup.
- Partner with Project Management team on project deliverables and customer communications.
- Collaborate with Quality Assurance (QA) team on regulatory and compliance requirements of the manufacturing process.
- Work with Quality Control (QC) team on developing sampling plans.
- Contribute to equipment validation for new customer/product introductions into the facility.
- Analyze and design process fit and scale-up in collaboration with vendors, customer technical experts, or Lonza's Process Development and MSAT teams.
- Design and perform experiments on scale-down processes in the MSAT lab to support technology transfer.
- Autorize and/or approve process-related documents, such as Process Overviews, APS protocols, development/investigative protocols, and reports.
- Develop and define training programs and requirements to facilitate integration of new manufacturing processes into our facility.
- Interact with customer technical experts as necessary to progress technology transfer.
Process Support:
- Perform technical review/approvals of batch records, process SOPs, deviations, change controls, training documents, protocols, development/investigative reports, CAPAs.
- Support investigations into process issues/deviations and coordinate associated troubleshooting activities, performing experiments in the MSAT small-scale cell culture process lab.
- Manage change control implementation for process changes/improvements and coordination of non-GMP/non-clinical runs.
- Lead/support pre-campaign preparation activities.
- Oversight of on-going trainings to ensure alignment between training and process requirements.
- Monitor manufacturing run process data and monitor for run-to-run consistency.
- Identify and drive implementation of process improvements as required.
- Support inspections and audits by customers and regulatory authorities as required.
- Support plant start-up and pilot/clinical/commercial run. Perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues in operations, and participate in the generation and assessment of required change controls.
Requirements:
This role requires a Degree in Chemical Engineering, Biotechnology, Chemistry, or a related discipline. Relevant experience in biotechnology process development, process support, research, or a related manufacturing environment is advantageous. Prior hands-on experience in adhered human cell culture experimental techniques and equipment is desired. Knowledge of Excel and Statistical Data Analysis tools is expected. Experience in using TrackWise for change control, effectiveness check, corrective actions, and preventive actions (CAPAs) is highly desirable. Excellent communication skills, outstanding action orientation, and ability to work well in a fast-paced, cross-functional technical environment are essential. Analytical with good technical writing skills is required.
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