gmpprocess developmenttechnology transferprocess validationcapascale upcell and gene therapyaseptic manufacturing
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Крутая вакансия
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Отличная возможность в глобальном лидере биофармацевтики в очень перспективном домене. Роль четко описана, но вопрос зарплаты придется решать на собеседовании, так как она не указана.
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Зарплата не указанаТрендовый доменЛидер индустрииПередовые технологииЧеткие задачи
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Senior Process Engineer, MSAT (CGT) (Cell and Gene Therapy): Supporting the transfer, scale-up, validation, troubleshooting, and optimization of customer manufacturing processes in a GMP aseptic manufacturing environment with an accent on technology transfer, process compliance, and technical documentation. Focus on conducting lab-scale experiments, monitoring production campaigns, managing change controls, and supporting audits and regulatory inspections.
Location: Tuas, Singapore
Company
hirify.global is a global life sciences contract manufacturer providing manufacturing services and technology platforms for biologics, pharmaceuticals, and cell and gene therapies.
What you will do
Lead or support technology transfer and scale-up of customer manufacturing processes.
Collaborate with global teams, vendors, and customers to implement transferred processes successfully.
Conduct lab-scale experiments, troubleshoot process issues, and drive process optimization.
Author and review technical documentation and training materials.
Monitor production runs, provide on-floor campaign support, ensure GMP compliance, and manage change controls.
Participate in audits and regulatory inspections.
Requirements
Degree in science or engineering.
5–10 years of experience in process development or life sciences.
Deep knowledge of cell and gene therapy, GMP, and aseptic manufacturing.
Strong collaboration and communication skills with clients and internal teams.
Nice to have
Experience with material assessment and continuous improvement projects.
Experience serving as a subject-matter expert for materials-related investigations and global discussions.
Experience managing quality events such as CRFs, nonconformances, and CAPAs.
Knowledge of advances in cell and gene therapy materials and experience mentoring team members.
Culture & Benefits
Exposure to biotech and established pharmaceutical customers.
Opportunity to work with manufacturing technologies for mammalian treatments and cell therapies.
Participation in a global manufacturing network focused on reliable, high-quality, and compliant services.
Work centered on ethical scientific problem-solving and developing ideas that improve patient lives.
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