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 and 0-2 years’ experience in related cGMP manufacturing operations; or high school degree and 3-5 years’ experience, or equivalent for Manufacturing Associate I
- Bachelor’s degree in a related scientific or engineering discipline and 2-5 years’ experience in related cGMP manufacturing operations; or high school degree and 4-6 years’ experience, or equivalent for Manufacturing Associate II
- Basic knowledge of upstream (cell culture or fermentation), downstream (purification and bulk filling) or manufacturing support unit operations is preferred
- Excellent written and verbal communication skills are required
- Fluent in reading and writing the English language
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
- Ability to compute rate, ratio, and percent and to draw and interpret graphs
- MS Office, ERP, EDMS, production equipment software, other
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 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 (i.e. SR, EPR and BR)
- Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities
- Participate and be accountable for workplace organization (5S)
Preferred Qualifications
- Experience in single-use platform technology is preferred
- Energetic, motivated, and dynamic individual
- Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor