Job Description
Job Summary: Responsible for manufacture of cell banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).
Essential Job Functions:
- Understands aseptic technique concepts
- Able to operate and maintain equipment
- Performs solution and material preparation
- Possesses basic technical knowledge and background
- Participates on and performs technical transfer activities
- Assists with the execution of validation activities
- Receives and organizes materials
- Identifies and communicates material discrepancies
- Uses some support systems (e.g. LIMS)
- Understands the concept of manufacturing processes and methods
- Collects and records scientific and process data per good document practices
- Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs)
- Follows and executes Standard Operating Procedures (SOPs)
- Follows and executes Batch Records (BRs)
- Participates in the development of technical documents such as non-conforming events and deviations
- Possess basic computer skills and able to efficiently use basic Microsoft application
Job Requirements:
- High School diploma and over 2 years of relevant experience or
- Associates’/Bachelor’s (science preferred) degree with 0-2 years of relevant or equivalent experience
- Aseptic Technique
- Cell Culture
- Cryopreservation