POSITION SUMMARY
You will be a key member of our Manufacturing team, responsible for manufacturing processes. Over time, this role will involve line management of a technical team. The candidate should have prior experience in manufacturing, specifically in the field of cell and gene therapy, ideally within aseptic sterile manufacturing.
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.
EXPERIENCE REQUIREMENTS
- 1 to 3 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/Life Science)
