Cell Manufacturing Specialist
Responsible for manufacturing activities for clinical materials
SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, human papillomavirus, and hepatitis B, and develops a broad and unique pipeline of T cell therapies, antibodies, and therapeutic vaccines against infections and to prevent and cure its associated cancers. Established and headquartered in Singapore, SCG combines regional advantages in Singapore, China and Germany, covering the entire value chain from innovative drug research and discovery, manufacturing, clinical development and commercialization. SCG collaborates with leading scientists and researchers to bring first-in-class and best-in-class medical products/technologies to enhance innovation in medical product development.
Key Responsibilities
Reporting to the Manufacturing Lead, Cell Manufacturing Specialist will be responsible for manufacturing activities for clinical materials and ensure all activities are according to SOP and GMP requirements including management of external manufacturing.
● Perform manufacturing activities for cell and gene therapy in a cleanroom setting.
● Participating in and facilitating technology transfers and final process development activities.
● Multitask and be involved in both cGMP manufacturing and/or validation studies concurrently.
● Ensuring raw materials are available as needed for manufacturing purposes including daily/weekly and/or monthly stocktakes.
● Documents production operations in corresponding batch records, logbooks and any controlled forms according to SOP ensuring accuracy and timely completion.
● Identify real time manufacturing issues and communicates them to team supervisor/manager to facilitate continuous improvement
● Ensuring cGMP compliance is always maintained throughout the facility, processes and documentations.
● Write and assist in implementation of technical SOPs
● Maintain laboratory instrument/equipment calibration and preventive maintenance
● Be accountable for the highest level of execution of regulatory strategies, and standards of quality compliance.
Any other tasks assigned by RO/management
Requirements
● Minimum Bachelor degree in a cell and molecular biology, medical technology, pharmaceutical sciences or any related life sciences and biotechnology field.
● Experience in a cGMP environment, or pharma / biotech manufacturing environment is a plus.
● Experience with aseptic techniques and cell culture work is preferred.
● Ability to work independently and in a team setting.
● Provides guidance and troubleshooting assistance as needed during a deviation in the process.
● Good to have knowledge of FDA/GMP regulations and standards in biotech industry
● Good to have experience writing technical SOPs
● Experience with Cell/Gene Therapy manufacturing is preferred
Note: This job description is not intended to be all-inclusive. The employee may be required to perform other duties as assigned.
