Biopharmaceutical Manufacturing Associate - Philadelphia, United States - Blue Ocean
Description
Overview:
As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required.
Responsibilities:
- Develop a comprehensive understanding of and be able to proficiently execute current cell therapy manufacturing process.
- Complete training sessions and ensure training documentation is maintained.
- Understands and complies with quality standards and requirements as documented.
- Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
- Supports technical transfer and additional research level testing activities.
- Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
Job Types:
Full-time, Contract
Pay:
From $24.00 per hour
Benefits:
- 401(k)
- 401(k)
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- High school or equivalent (preferred)
Experience:
- Manufacturing: 1 year (preferred)
- Cell culture: 1 year (preferred)
- Cell biology: 1 year (preferred)
- Mammalian cell culture: 1 year (preferred)
- GMP: 1 year (preferred)
Work Location:
In person
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