Lead MSAT Purification Engineer - Hybrid Singapore

lonza biologics tuas pte. ltd.; Singapore; Híbrido; Confidential; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Dynamic culture

Inclusive workplace

Recognition programs

Daily bus

Medical insurance

Resumo da oferta

Lonza Singapore is seeking a Lead Engineer for MSAT - Purification to lead the preparation, execution, process monitoring and post-campaign activities for cell culture or purification stages at Lonza Singapore production facility. You will work primarily in the office with the option to work remotely up to 20%.

The role requires over 5 years in biotechnology process development, process support, research or related manufacturing, and a graduate degree in chemical/biochemical engineering or

Qualificações

• 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.

Responsabilidades

• 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 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 GMP and commercial runs, perform technical investigations, and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues for purification processes.
• 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.

Conhecimentos

Biotechnology process development

Formação académica

Graduate degree in Chemical engineering, biochemical engineering, biochemistry/chemistry/biological science, or related field

Descrição da oferta de emprego

Lonza Singapore is seeking a Lead Engineer for MSAT - Purification to lead the preparation, execution, process monitoring and post-campaign activities for cell culture or purification stages at Lonza Singapore production facility. You will work primarily in the office with the option to work remotely up to 20%.

The role requires over 5 years in biotechnology process development, process support, research or related manufacturing, and a graduate degree in chemical/biochemical engineering or