Responsibilities
- Executes tasks in compliance with current Good Manufacturing Practice standards within a biologics manufacturing setting
- Collaborates with engineering staff on equipment setup and calibration activities
- Conducts rework procedures and performs quality checks on parts, components, and final materials
- Utilizes advanced software platforms such as LIMS, SAP, and automated control systems for data collection and analysis
- Makes real-time adjustments to products, instruments, or machinery during operations
- Helps establish or refine methods and protocols for manufacturing process control or modification
- Packages and ships completed materials according to procedures
- Monitors and manages inventory levels to support production continuity
- Collects samples from raw materials and in-process batches for testing
- Operates and maintains glassware washing and autoclave equipment
- Prepares buffers and growth media used in production processes
- Conducts equipment cleaning and sterilization through CIP and SIP procedures
- Manages cell culture operations from initial vial thawing through large-scale production
- Performs column chromatography for product purification
- Executes tangential flow filtration for concentration and diafiltration steps
