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Manufacturing Associate II – Night Shift
Company | KBI Biopharma |
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Location | Durham, NC, USA |
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Salary | $24 – $31.25 |
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Type | Full-Time |
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Degrees | Bachelor’s |
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Experience Level | Mid Level, Senior |
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Requirements
- Manufacturing Associate II- Bachelor’s degree in a related scientific or engineering discipline and 2-5 years’ experience in related cGMP manufacturing operations; or high school diploma and 4-6 years’ experience, or equivalent
- Basic knowledge of upstream processing- cell culture or fermentation
- Experience in single-use platform technology is preferred
Responsibilities
- Manufacture bulk intermediates and drug substances per manufacturing batch records in compliance with quality, 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 records and logbooks following GDP at the time of execution
- Utilize and perform maintenance on equipment per applicable SOP
- Ensure all materials are issued and accounted for during the execution of a record
- Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities
- Participate and be accountable for workplace organization
Preferred Qualifications
- Experience in single-use platform technology is preferred