Manufacturing Associate I /II

Job Description 7PM-7AM / 2*2*3 Manufacturing Schedule The Manufacturing Associate I/II - Nights will perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environment. Responsibilities include executing tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy. The role involves unit operations such as media/buffer preparation, bioreactor operations, aseptic techniques, chromatography, ultrafiltration, and drug substance filling. Candidates must maintain process ownership, facility upkeep, and thorough documentation review to ensure compliance. The ideal candidate should have a basic understanding of cell culture, fermentation, or purification unit operations, with preference given to those experienced in single-use platform technology. Strong written and verbal communication skills are essential. The role requires an energetic, motivated, and dynamic individual who is highly organized and capable of maintaining efficiency and a positive demeanor in a fast-paced, multitasking environment. Primary Responsibilities 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, BR). 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. Minimum Requirements 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. 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. Additional Requirements Excellent written and verbal communication skills are required. Energetic, motivated, and dynamic individual. Must be organized and able to focus in a fast-paced, multitasked environment, maintaining operational efficiency and a positive demeanor. Language Ability 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 the organization. Reasoning Ability 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. Math Ability 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. Physical Demands 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 ladder may be required when setting up bioreactors. Working Conditions 12‑hour shifts, which may include work overnight. Work within a cGMP manufacturing biotechnology facility which requires clean-room operations, donning clean-room attire, and maintaining good personal hygiene. Regular use of equipment and materials that include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards; noise level in the environment is moderate to high. Equal Employment Opportunity Statement KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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. #J-18808-Ljbffr KBI Biopharma