Senior / Research Officer (DMOEL)

The Senior Research Office/ Research Officer will oversee the progress of research studies under the Program - An open-label, Phase I study of armored B7-H3 CAR-T Cell Therapy in Ovarian Cancer, with the supervision of the Principal investigator Dr Elaine Lim. They will perform a variety of research and translational activities which include technology transfer, planning and execution of clinical manufacturing of cell therapy products for ovarian cancer.

Key Duties:

1. Technology Transfer & Process Translation

• Compile, prepare and maintain technology transfer protocols and project related documentation.
• Draft or revise documentation such as materials specification, risk assessments etc.
• Preparation and execution of engineering / training runs
• Translate research protocols to Good Manufacturing Practice (GMP) compliant workflows
• Perform aseptic process simulations per GMP guidelines.

2. Manufacturing of cell therapy products

• Support manufacturing cell therapy products in a GMP facility, which may include processing, product storage, shipment and sampling activities.
• Comply with GMP procedures, safety guidelines and other applicable regulatory requirements.
• Perform aseptic processing and/or QC sampling as required.
  Document or review batch records and associated documentation where required. Escalate non-conformance or discrepancies to RO prior to batch release.

3. Perform tasks and support all aspects of the research project

• Perform stock check and timely top up of reagents and consumables to support manufacturing.
• Manage procurement of project-related materials, including vendor qualification and coordination.
• Coordinate equipment qualification, validation and maintenance activities where required.
• Support noncompliance investigations and change controls as required.
• Draft job description, training plans and complete relevant GMP related training to work within the cleanroom environment.

4. Perform other related duties

• Act as liaison between NCCS, external biotech partners and manufacturing facility to coordinate meetings, track project milestones and status.
• Review agreements and manage administrative and grant-related matters
• Maintain proper version control and document tracking of all project-related documentation.

Key Requirements:

• Bachelor's/Master of Science degree in related technical discipline (biology, cell biology, biomedical science, biochemistry or molecular biology)
• Prior experience in biopharmaceutical, cell/gene therapy manufacturing with exposure to GMP documentation and cleanroom operations will be an advantage.
• Proficient in cell culture or molecular work with sterile or aseptic processing knowledge and experience.
• Working knowledge of GMP and GDP with ability to translate research stage protocols into GMP compliant manufacturing workflows.
• Possess strong written and verbal communication skills, with the ability to draft technical documentation and manage different stakeholders.
• Prior exposure to equipment qualification, vendor/procurement coordination or project/grant administration is an advantage.
• Team player, able to build working relationships with internal and external stakeholders
• Able to work independently and complete tasks assigned with little supervision.
• Willing to undergo GMP training and work in cleanroom environment for extended periods.
• Highly motivated, proactive and willing to learn
• Able to adapt to fast paced and changing environment
• Attention to details