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[BioTechies] Production Executive

  • BioTechies
  • Johor
  • Applications have closed

Website Cytomed Therapeutics (M) Sdn Bhd

Job Description
We are looking for a highly driven individual to join as a Production Executive 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.

Responsibilities:
• To adhere to GMP and Quality Management System (QMS) ;
• 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 perform and ensure proper documentation recording;
• To conduct production operations as per established procedures;
• To record production operations as required;
• To assist in validation on production equipment and processes;
• To inform Production Manager / Assistant Manager of any deviation and out of specification happen during operation truthfully and in a timely manner;
• To record consumables and raw materials used in BMR;
• To inform Production Manager / Assistant Manager when inventory is low and is responsible for re-ordering of consumables;
• To use raw materials and consumables approved by the Quality Control Department only;
• To record product complaints;
• To assist investigating product complaints when necessary;
• To participate in self-inspection (internal audit);
• To adhere to procedures to ensure the sterility of materials being produced; and
• Assist in all other tasks assigned from time to time.

Job Requirements:
• Degree in Biomedical Sciences/ Biological Science/ Biotechnology or related field and above
• Possess human primary and/or stem cell and/or immune cell culture experience a must (minimum
1-year experience) – 2 years’ experience is highly favorable.
• Experience in GMP manufacturing and GMP environment.
• Molecular cloning and molecular work would be an advantage.