about the company
Our client is a biotech company reputable for their immunotherapies with the aim to meet the needs in cancer treatment. They’re now looking for a Manufacturing Biotechnologist to join their team during this exciting time.
about the job
- Ensure that biopharmaceutical products are manufactured to the highest standard of quality within a GMP (Good Manufacturing Practice) regulated environment.
- Be responsible for the production of CAR-T and TCR-T cell products in accordance with the Batch Manufacturing Record (BMR).
- As technical owner, be a reviewer of manufacturing documents such as batch manufacturing records, SOPs, and monitoring/log sheets
- Oversee closure of batch record review and deviations write ups to ensure timely batch release of the final product.
- Observe strict aseptic and sterile manufacturing practices for cell culture and other cleanroom related activities to ensure compliance to cGMP
- Utilize manufacturing process operations and commercial facility experience to participate in cross functional working groups to drive the design and implementation of manufacturing related workflows.
- Ensure and 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.
job requirement
- Degree in Biotechnology/Life Sciences or equivalent
- Minimum 1 year in a GMP biopharmaceutical manufacturing related role.
- Must have knowledge/experienced in cell gene therapy
- Familiar with a GMP environment, fundamental quality systems and regulatory compliance expectations on the manufacturing floor.
If you are interested in the position, kindly apply directly or send your CVs to yiling.tan@randstad.com.sg.
We regret that only shortlisted candidates will be contacted.
EA: 94C3609 / Reg: R21103172
