- Durham, North Carolina, United States
- 0–6 years
Manufacturing Associate I/II (Nights) responsible for execution of upstream or downstream production activities for early and late-phase cell culture programs within a GMP environment.
Responsibilities
- Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations.
- Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
- Document each task involving manufacturing procedures (i.e. SR’s, EPR’s and BR’s) following GDP at the time of execution.
- Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
- Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities.
Requirements
- Bachelor’s degree in a related scientific or engineering discipline
- High school diploma
- Nice to have: Single-use platform technology