Manufacturing Associate I​/II - Night Shift

Position Summary

This position is on a 2-2-3 shift, 6p-6a. The Manufacturing Associate I/II – Downstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment. The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to cell culture clarification, chromatography operations using the Cytiva UNICORN software application, viral inactivation, ultrafiltration/diafiltration systems, and various filtration techniques utilizing single‑use technologies.

Various analytical tools (SoloVPE, pH/Conductivity meters) and general biotech auxiliary equipment are used daily. Following task execution, the associate reviews the production records (SRs, ERPs and BRs) to ensure GxP compliance.

• Purify cell culture products per batch records in compliance with quality standards, company policies, and regulations.
• Use chromatography, filtration, and viral reduction techniques, up through bulk fill of drug product or intermediate.
• Operate in a cleanroom environment and implement aseptic controls, gowning, and cleaning procedures.
• Document each task (SR, ERP,  ) following GDP at the time of execution.
• Ensure all materials and items are issued and accounted for during record execution.
• Apply current Good Manufacturing Practices (cGMP) to all tasks.
• Participate in room 5S activities.
• Perform maintenance on equipment per applicable SOPs.

• High school diploma.
• Experience in a regulated industry or demonstrated knowledge of downstream or purification unit operations.
• Ability to follow written instructions.
• Excellent written and verbal communication skills.
• Organized and able to focus in a fast‑paced, multi‑tasked environment, maintaining operational efficiency and a positive demeanor.
• Energetic, motivated, and dynamic individual with high attention to detail.
• Acceptance of a 12‑hour schedule that includes weekends, nights, and holidays.
• COVID‑19 vaccination – proof of vaccination with an FDA‑approved or EUA vaccine is required.

• Associate’s or Bachelor’s degree in a related scientific or engineering discipline.
• Biowork certification.
• Experience with single‑use platform technology.
• Experience in a CDMO.

Salary: $24.00–$31.25 per hour, plus a shift differential.

Benefits include an annual bonus structure, medical, dental, and vision coverage, paid PTO and holidays, 401(k) matching with 100% vesting in 60 days, and employee recognition programs.

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.