Manufacturing Biotechnologist

4 days ago


Singapur, Singapore BIOSYNGEN PTE. LTD. Full time
Job Title: Manufacturing Biotechnologist

At BIOSYNGEN PTE. LTD., we are seeking a highly skilled Manufacturing Biotechnologist to join our team. As a key member of our Manufacturing team, you will be responsible for ensuring the highest standard of quality in biopharmaceutical product manufacturing within a GMP regulated environment.

Key Responsibilities:
  • Ensure compliance to current Good Manufacturing Practice (cGMP) and GDocP standards.
  • Responsible for the production of CAR-T and TCR-T cell products in accordance with the Batch Manufacturing Record (BMR).
  • Review and ensure accuracy of manufacturing documents such as batch manufacturing records, SOPs, forms, and monitoring / log sheets.
  • Oversee closure of batch record review and deviations write ups to ensure timely batch release of the final product.
  • Participate in cross-functional working groups to drive the design and implementation of manufacturing related workflows.
  • Maintain the condition of GMP Facility, cleanroom, and associated manufacturing equipment.
  • Develop comprehensive safety risk assessments and adhere to all environment, health, and safety (EHS) guidelines.
Requirements:
  • 1 to 3 years of experience in a GMP biopharmaceutical manufacturing related role.
  • Familiarity with a GMP environment, fundamental quality systems, and regulatory compliance expectations on manufacturing floor.
  • Working understanding of Operations, QC, QA, Process Development, Supply Chain, and related functions.
Work Environment:
  • Work in a cleanroom environment.
Education:
  • Minimum Degree in Biotechnology/Life Science.


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