Lead Engineer, MSAT - Purification

About the company

My client is a big Pharmaceutical Company in Singapore.

Your tasks

• Process Support:Lead the preparation, execution, process monitoring, and post-campaignactivities for cell culture or purification stages of the customer’smanufacturing processes at Singapore production facility. Becomeproficient with all processes in the facility and develop the ability tosupport/lead activities across multiple processes.
• Monitor processeson a regular basis to further understand process behavior and prospectivelyidentify process issues. Develop the ability to generalize issues acrossprocesses. Lead investigations into process trends, issues, or deviationsinvolving multiple departments and customers. Write change requests and driveto implementation.

• Review purificationprocess manufacturing batch records and provide technical input to MFGtechnical document writing specialists. Identify training needs and providetraining materials for MFG operators on cell culture or purification processbatch records.
• Work with MFG toupdate process batch records to enable robust manufacturing operations. SupportGMP and commercial runs, perform technical investigations, and help authortechnical reports to support close-out of deviations, trouble-shoot processexcursions/issues for purification processes.

• Support Preparationof Annual Product Review (APR) and Continued Process Verification (CPV) summaryreports, perform work-stages to support customer BLA filing.
• Maintain processdatabases and monitor batch-to-batch consistency of operations. Supportinspections and audits by customers and regulatory authorities. Providetechnical mentorship and share process knowledge with MSAT team members andother departments. Uphold data integrity principles in accordance with policies. Proactively evaluate, identify, and improve the data integrityprocess. Any other duties as assigned by your Supervisor/Manager.

Requirements

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 the purification domain.

How to apply

Director Recruitmatic Pte. Ltd. (22S1186)

Other

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