Manufacturing Biotechnologist

2 weeks ago

Singapore BIOSYNGEN PTE. LTD. Full time

**Position Summary
You will be a key member of our Manufacturing team and will be responsible for providing technical leadership for Manufacturing processes. In due course, this role involves line management of technical team. The candiate should have prior experience in manufacturing in the are of cell and gene therapy, ineally within aseptic sterile Manufacturing, and experience in leading a team.

Subjected to work experience, seniority of the role will be accorded.

**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**
- 5 to 8 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, ect) 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.

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