Senior MSAT Engineer: Cell & Gene Therapy (GMP)

Lonza; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Comprehensive benefits

Daily shuttle bus

Medical insurance for you

Family coverage options

Job summary

Lonza Singapore is seeking a Lead Engineer for MSAT (CGT) to lead technology transfer, scale-up, and GMP runs. You will collaborate with Manufacturing, QA, QC, Validation and Project Management to enable pilot and commercial runs, ensuring process performance and traceability.

You will guide scale-down studies, drive continuous improvements, and provide on-floor oversight during GMP operations while supporting regulatory inspections and plant start-up activities.

Qualifications

• Strong expertise in cell & gene therapy, GMP/ATMP, and aseptic manufacturing.
• Hands-on experience in adherent human cell culture.
• Experience in deviation management, change control, CAPA (TrackWise preferred).
• Solid data analysis skills (Excel/statistical tools).
• Knowledge of Lean/Six Sigma and structured problem-solving tools.
• A proactive, solutions-oriented communicator who thrives in fast-paced, cross-functional environments

Responsibilities

• Lead and support technology transfer of customer manufacturing processes into Lonza Bioscience Singapore.
• Partner cross-functionally with Manufacturing, QA, QC, Validation, Supply Chain, and Project Management to enable successful pilot, clinical, and commercial runs.
• Design and execute scale-down studies and process fit assessments to support tech transfer and scale-up.
• Provide on-floor technical oversight during GMP runs, troubleshooting process deviations and driving investigations.
• Monitor process performance, ensure run-to-run consistency, and implement continuous improvements.
• Author and review process documents, protocols, reports, and change controls.
• Support regulatory inspections, audits, and plant start-up activities.

Skills

Cell & gene therapy

GMP/ATMP

Aseptic manufacturing

Adherent cell culture

Deviation management

CAPA (TrackWise)

Data analysis (Excel)

Tools

TrackWise

Excel

Job description

Lonza Singapore is seeking a Lead Engineer for MSAT (CGT) to lead technology transfer, scale-up, and GMP runs. You will collaborate with Manufacturing, QA, QC, Validation and Project Management to enable pilot and commercial runs, ensuring process performance and traceability.

You will guide scale-down studies, drive continuous improvements, and provide on-floor oversight during GMP operations while supporting regulatory inspections and plant start-up activities.