Lead Engineer, MSAT (Cell and Gene Therapy)

TL;DR

Lead Engineer, MSAT (Cell and Gene Therapy): Leading technology transfer of customer manufacturing processes into hirify.global Bioscience Singapore with an accent on cross-functional partnership and GMP run oversight. Focus on designing scale-down studies, troubleshooting process deviations, and ensuring run-to-run consistency for clinical and commercial batches.

Location: Singapore (Tuas)

Company

Global leader in the life sciences industry, manufacturing advanced medicines across 30+ sites worldwide.

What you will do

• Lead and support the technology transfer of customer manufacturing processes into the Singapore site.
• Partner cross-functionally with Manufacturing, QA, QC, Validation, Supply Chain, and Project Management.
• 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 deviations and driving investigations.
• Monitor process performance and implement continuous improvements to ensure run-to-run consistency.
• Author and review critical process documents, protocols, reports, and change controls.

Requirements

• 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, and CAPA (TrackWise preferred).
• Solid data analysis skills using Excel and statistical tools.
• Knowledge of Lean/Six Sigma and structured problem-solving tools.
• Must be based in or authorized to work in Singapore (Tuas).

Culture & Benefits

• Agile career paths within a dynamic and inclusive working culture.
• Compensation programs that recognize and reward high performance.
• Daily company shuttle bus service from MRT locations to the Tuas site.
• Fully paid medical insurance with options for partially subsidized family enrollment.
• Commitment to diversity, equity, and an ethical workplace.