Lead Engineer, MSAT - Purification

lonza biologics tuas pte. ltd.; Singapore; Hybrid; Confidential; Full time

Benefits offered by this job

Dynamic culture

Inclusive workplace

Recognition programs

Daily bus

Medical insurance

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Biotechnology process development

Education

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

Job description

Lead Engineer, MSAT - Purification

The actual location of this job is in Singapore.

This is an office-first role. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Daily company bus from the MRT location near your home to and from the Tuas site.
• Fully paid medical insurance, and option to enroll family members at partially subsidized premiums.

What you will do:

• 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.

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.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.