Scientist - Philadelphia, United States - Blue Ocean
Description
Manufacturing Associate IIOverview:
Responsible for manufacture of Master and Working 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).
Responsibilities:
- Understands aseptic technique concepts
- Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance
- Able to operate and maintain equipment
- Understands the basic operations and functions of equipment and is able to perform basic troubleshooting
- Performs solution and material preparation
- Possesses basic technical knowledge and background in the industry
- Possesses basic and fundamental engineering and mechanical knowledge
- Possesses basic and fundamental facility startup experience
- Has participated in facility startups
- Participates on and performs technical transfer activities
- Assists with the execution of validation activities
- Receives and organizes materials
- Performs material procurement activities
- Identifies, communicates and resolves material discrepancies
- Uses most support systems (e.g. LIMS) with some demonstrated proficiency
- Understands the concept of and has performed or experience with manufacturing processes and methods
- Identifies and understands acceptable and unacceptable practices and is able to make on the spot corrections to performance
- Collects, records, reviews, performs basic analysis and identify basic trends of scientific and process data per good document practices
- Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and starts to understand 'why' behind the regulations
- Follows and executes Standard Operating Procedures (SOPs)
- Revises and authors simple SOPs
- Follows and executes Batch Records (BRs)
- Revises and authors simple BRs
- Trains others on basic SOPs, equipment and unit operations
- Participates and provides information in the development of technical documents such as nonconforming events and deviations
- Suggests and participates in continuous improvement ideas
- Identifies, participates and suggests solutions to technical problems
- Identifies, suggests and seeks out for decision making
- Participates and supports regulatory inspections and client audits
- Interacts on a mínimal basis with groups that support manufacturing
- Cross trains in other areas and may be utilized to perform above job functions across the entire site
- Performs well under direct supervision and starts to work independently on basic tasks and processes
Pay:
From $26.00 per hour
Schedule:
- 10 hour shift
- 12 hour shift
- 8 hour shift
- Day shift
Education:
- High school or equivalent (preferred)
Experience:
- Cell culture: 2 years (preferred)
- Mammalian cell culture: 2 years (preferred)
- Aseptic technique: 1 year (preferred)
Work Location:
In person
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