Senior Medical Laboratory Scientist (Cell Therapy ), NCIS

Overview*

NCIS is establishing a new Stem Cell Therapy Hub (SCTH) as part of expansion of its Specialised Programmes and to become a Reference Centre of Excellence. We are looking for a Cell Therapy Specialist to be part of the Cell Therapy team in the organisation.

The candidate will be involved in the daily and manufacturing operations for cell therapy products, either as part of Stem Cell Transplant program or NCIS Specialised Project. This position is also involved in external collaboration activities such method transfer, GMP documentation, translational and process development, and cell therapy manufacturing. The candidate is encouraged to write white paper and research paper for publication.

Job Responsibilities*

·         Perform manufacturing procedures in accordance with regulatory guidelines for cell therapy projects by SCTH.

·         Support QA for any process and manufacturing quality related issues.

·         Support technical transfer for developed process or analytical methods.

·         Initiate and review study protocols, reports and other documentations in adherence to GDP principles.

• Involve in lab, cleanroom or facility activities, or studies such as process & equipment qualification/validation.
• Manage change controls and deviations of GMP runs for manufacturing.
• Support CMC documentation and submission for clients.
• Perform Clinical Cell Therapy administration and product handling.
• Perform translational and process development work.

·         Perform root cause analysis for operational related deviations and investigations.

·         Any other duties assigned by supervisor.

Requirements*

·         Bachelor’s degree in engineering (Chemical / Biomedical), Biotechnology, Life Science or equivalent. Post Graduate Diploma or Professional Degree will be considered an advantage.

·         More than 3 years of relevant experiences in Cell and Gene/Biologics/Vaccines manufacturing/CMC activities.

·         Experience in GMP practices applicable to cell therapy manufacturing processes

·         Experience with technical method transfer.

·         Experience and competent with aseptic technique for cell culture.

·         Experience and competent with QbD methodology for process development and characterisation will be an advantage.

·         Experience with regulatory requirements related to cell therapy release, manufacturing process qualification and validation will be an advantage.

·         Proficient in technical writing.

·         No colour blindness (will be determined by medical checkup).