Manufacturing Biotechnologist

7 days ago

Singapore BIOSYNGEN PTE. LTD. Full time

**ESSENTIAL JOB FUNCTIONS**
- As a key member of the team you will be ensuring that biopharmaceutical products are manufactured to the highest standard of quality within a GMP (Good Manufacturing Practice) regulated environment.
- Observe strict aseptic and sterile manufacturing practices for cell culture and other cleanroom related activities to ensure compliance to current Good Manufacturing Practice (cGMP).
- You will either 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, forms, and monitoring / log sheets whilst ensuring accuracy and compliance to cGMP and GDocP standards.
- Responsible for overseeing closure of batch record review and deviations write ups to ensure timely batch release of the final product.
- Utilize manufacturing process operations and commercial facility experience to participate in cross functional working groups as a user representative 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.
- Train and lead a team of biotechnologists in the day-to-day operations.

**EXPERIENCE REQUIREMENTS
- 3 to 5 years in a GMP biopharmaceutical manufacturing related role.
- Applicant must be familiar with a GMP environment, fundamental quality systems (deviation, corrective action preventative action, change control, etc) 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.

**EDUCATIONAL REQUIREMENTS **
- Minimum Degree (Biotechnology/Chemical Engineering/Life Science)

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