Hospital à United States

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.

• Bachelor's degree in biomedical science or related studies.
• Experience in working in an GMP facility and has experience in manufacturing in a GMP setting.
• Familiar with GMP processes and validation runs and writing SOPs for GMP processes.
• Leadership skills - past experience in managing and leading a team.
• Good communicator and understand cell therapy lingo in clinical trial, scientific and technological aspects.