MSAT Lead Engineer - Cell & Gene Therapy

Lonza Group Ltd.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Daily bus from MRT to Tuas site

Fully paid medical insurance

Global benefits list

Job summary

Lonza Singapore is seeking a Lead Engineer, MSAT (CGT) to drive technology transfer of customer manufacturing processes and oversee GMP operations on the floor. You will collaborate with Manufacturing, QA/QC, Validation, Supply Chain and Project Management to ensure successful pilot, clinical and commercial runs.

You will design scale-down studies, lead investigations, and implement process improvements while guiding regulatory inspections and 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.
• Solid data analysis skills (Excel/ statistics).
• Knowledge of Lean/Six Sigma and structured problem solving.

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

Change Control

CAPA

Data Analysis

Lean Six Sigma

Cross-functional Communication

Job description

Lonza Singapore is seeking a Lead Engineer, MSAT (CGT) to drive technology transfer of customer manufacturing processes and oversee GMP operations on the floor. You will collaborate with Manufacturing, QA/QC, Validation, Supply Chain and Project Management to ensure successful pilot, clinical and commercial runs.

You will design scale-down studies, lead investigations, and implement process improvements while guiding regulatory inspections and start-up activities.