gmplean six sigmatechnology transferchange controlcapadeviation managementatmphuman cell culturecell and gene therapyaseptic manufacturing
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Крутая вакансия
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Качественная лид-позиция в глобальном биотех-гиганте в передовом сегменте. Описание максимально прозрачное, а домен — один из самых перспективных в медтехе.
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Зарплата не указанаТрендовый доменЛидер индустрииПонятный scope
Оценка от Hirify AI
Описание вакансии
Текст:
Hirify AI/Оригинал
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
hirify.global 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.