Manufacturing Associate I - Nights
On-siteDurham, North Carolina, United States
Job Summary
Execute upstream or downstream production activities for early and late-phase Cell Culture programs in a GMP environment. Perform unit operations including media/buffer preparation, bioreactor operations, aseptic techniques, and drug substance filling while adhering to SOPs, batch records, and cGMP standards. Maintain cleanroom operations, ensure proper documentation of procedures, and uphold 5S standards and equipment maintenance. Work 12-hour shifts including overnight rotations within a cGMP biotechnology facility. This role supports KBI Biopharma's mission to advance important medicines to patients through a collaborative, team-oriented environment focused on quality and efficiency.
Required Qualifications
- Bachelor's degree in a related scientific or engineering discipline
- 0-2 years of GMP manufacturing experience
- high school diploma
- 3-5 years of related GMP manufacturing experience
- Fluent in English language both reading and writing
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records
- Ability to write routine reports and correspondence
- Ability to speak effectively before groups of employees of organization
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- 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
- Working 12-hour shifts which may include working overnight
- Working within a cGMP manufacturing biotechnology facility which requires clean room operations
- Clean room attire when entering clean room areas
- Maintaining good personal hygiene
- Use of ladder when setting up bioreactors
Desired Qualifications
- basic understanding of cell culture, fermentation, or purification unit operations
- experience in single-use platform technology
- Energetic, motivated, and dynamic individual
- Highly organized
- Capable of maintaining efficiency and a positive demeanor in a fast-paced, multitasking environment
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