Manufacturing Associate I/II
| Company | KBI Biopharma |
|---|---|
| Location | Durham, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Entry Level/New Grad, Junior, Mid Level |
Requirements
- Bachelor’s degree in a related scientific or engineering discipline with 0-2 years’ experience in related GMP manufacturing operations for Manufacturing Associate I
- High school diploma with 3-5 years’ experience, or equivalent for Manufacturing Associate I
- Bachelor’s degree in a related scientific or engineering discipline with 2-5 years’ experience in related GMP manufacturing operations for Manufacturing Associate II
- High school diploma with 4-6 years’ experience, or equivalent for Manufacturing Associate II
- Basic knowledge of downstream (purification, filtration, bulk filling)
- Fluent in English language both reading and writing
- Must be organized and able to focus in a face-paced, multi-tasked environment
Responsibilities
- Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, 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 procedures (i.e. SRs, EPRs and BRs) 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 (i.e. SR, EPR and BR)
- Demonstrate, apply and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks and responsibilities
- Participate and be accountable for room 5S
Preferred Qualifications
- Basic knowledge of downstream (purification, filtration, bulk filling) is preferred
- Experience in single-use platform technology is preferred