Эта вакансия в архиве

Посмотреть похожие вакансии ↓
Company hidden
обновлено 2 месяца назад

Lead Engineer, MSAT (CGT)

Формат работы
onsite
Тип работы
fulltime
Грейд
lead
Английский
b2
Страна
Singapore

Описание вакансии

Текст:
/
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.