About the Role:

We are looking for a highly driven individual to join as a Production Specialist in the field of cancer immunotherapy and human stem cells. Candidate will work closely with a team of research scientists for manufacturing of cell therapy products, research and development so knowledge of Good Manufacturing Practice (GMP) is a highly favorable. This position offers an unique opportunity to apply robust human cell culture skills in a translational setting.

Job Requirements:

• To adhere to GMP and Quality Assurance System;
• To attend training, including but not limited to cell culture training for relevant production and all necessary GMP related training in order to achieve the desired competency level;
• To undergo medical examination and records are submitted to Quality Department;
• To assist ensuring equipment in the Production Department are maintained and calibrated;
• To assist ensuring equipment in the Production Department are validated;
• To adhere to procedures used in the Production Department;
• To ensure proper documentation recording;
• To conduct production operations as per established procedures;
• To record production operations as required;
• To conduct necessary validation on production equipment and processes;
• To report all deviation and out of specification operation during operation truthfully and in a timely manner;
• To maintain and keep track of inventory used in manufacturing;
• To inform Production Manager/ Assistant Production Manager when inventory is low and is responsible for re-ordering of consumables;
• To only use approved materials approved by the Quality Control department;
• To record product complaints;
• To assist investigating product complaints when necessary;
• To participate in self-inspection;
• To adhere to procedures to ensure the sterility of materials being produced; and
• Assist in all other tasks assigned from time to time.

Location: Johor Bahru, Johor