updated 2 months ago
Lead Engineer, MSAT (CGT)
Vacancy from Hirify Global, list of international tech companiesPlus is required to make matches and apply
Match & Cover letter
Plus required for matching with this vacancy
Job description
Text:
TL;DR
Lead Engineer, MSAT (CGT) (Cell and Gene Therapy): Leading technology transfer and manufacturing process support for pilot, clinical, and commercial runs in a GMP environment with an accent on scale-down studies, process fit assessments, and aseptic manufacturing. Focus on providing technical oversight during GMP runs, troubleshooting deviations, driving investigations, and implementing continuous process improvements.
Location: Tuas, Singapore; onsite
Company
is a global life sciences manufacturer supporting the development and production of medicines across more than 30 sites worldwide.
What you will do
- Lead and support technology transfer of customer manufacturing processes into the Singapore bioscience site.
- Partner with Manufacturing, QA, QC, Validation, Supply Chain, and Project Management to enable pilot, clinical, and commercial runs.
- Design and execute scale-down studies and process fit assessments for technology transfer and scale-up.
- Provide on-floor technical oversight during GMP runs, troubleshoot process deviations, and drive 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.
Requirements
- Strong expertise in cell and gene therapy, GMP/ATMP, and aseptic manufacturing.
- Hands-on experience with adherent human cell culture.
- Experience in deviation management, change control, and CAPA; TrackWise experience is preferred.
- Solid data analysis skills using Excel and statistical tools.
- Knowledge of Lean/Six Sigma and structured problem-solving tools.
- Proactive, solutions-oriented communication skills for fast-paced, cross-functional environments.
Culture & Benefits
- Agile career development and a dynamic working culture.
- Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
- Performance-based compensation programs.
- Daily company bus service from a nearby MRT location to the Tuas site.
- Fully paid medical insurance, with partially subsidized family coverage available.
Be careful: if the employer asks you to log into their system using iCloud/Google, send codes/passwords, or run code/software, don't do it - these are scammers. Always click "Report" or contact support. More in guide →