Manufacturing Associate I​/II - Solution Prep; Nights

Job Description

7PM-7AM / 2
* 2*3 Manufacturing

Schedule:

The Manufacturing Associate I/II - Solution Prep will perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environment.

• Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations.
• Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures.
• Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR,  ).
• Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities.
• Maintain and uphold 5S standards in the manufacturing environment.
• Operate and perform maintenance on equipment per applicable Standard Operating Procedures.

• Manufacturing Associate I:
  Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience.
• Manufacturing Associate II:
  Bachelor's degree in a related scientific or engineering discipline with 2-5 years of GMP manufacturing experience; OR high school diploma with 4-6 years of related GMP manufacturing experience.
• Basic knowledge of cell culture, fermentation or purification unit operations is preferred.
• Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills are required.
• 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.
• Language Ability:
  Fluent in English language for reading, writing, and speaking.
• 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, and to speak effectively before groups of employees.
• Reasoning Ability:
  Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Math Ability:
  Perform basic arithmetic (add, subtract, multiply, divide) in all units of measure, and compute rate, ratio, percent, and interpret graphs.

Standing and sitting for long periods of time may be required. Lifting, pushing, and pulling may be required for stocking and movement of equipment. The use of a ladder may be required when setting up bioreactors.

The job requires working 12‑hour shifts, which may include overnight duty. Work occurs in a cGMP manufacturing biotechnology facility requiring clean‑room operations, donning of clean‑room attire, and maintenance of good personal hygiene. The employee regularly utilizes equipment and materials that include mechanical hazards, chemical hazards, electrical hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.