
Enable job alerts via email!
A leading healthcare institution in Singapore is seeking a qualified professional to support technology transfer in cell and gene therapy processes. The role involves regulatory compliance, cross-functional communication, and team management. Applicants must have a Bachelor's degree in biomedical sciences with experience in GMP settings and strong communication skills.
Support the technology transfer of new cell and gene therapy processes from collaborators in SingHealth to a GMP environment - Namely ACTRIS (Advanced Cell Therapy and Research Institute, Singapore).
Perform facility fit and gap assessment for introduction of new projects, including evaluating suitable materials, equipment and technology platforms.
Provide technical support for aseptic process simulations, process troubleshooting and investigations during process validation and clinical manufacturing.
Serve as the primary point of contact between SingHealth PIs/collaborators and ACTRIS GMP team to troubleshoot and resolve complex challenges.
Work with suitable partners (e.g. ASTAR) and clinical collaborators to translate research protocols into actionable GMP processes.
Support the preparation and review of Chemistry, Manufacturing, and Controls (CMC) documentation, Master Batch Records (MBRs), Validation Protocols and Standard Operating Procedures (SOPs) to ensure GMP compliance.
Support discussion with regulatory bodies (eg. HSA) to facilitate clinical trial reviews and approvals.
Work closely with multidisciplinary teams, fostering collaboration across clinical and research functions.
Train and mentor junior team members to support technology transfer of new projects.