Manufacturing Associate I/II (Nights) (Biotech)

Location: Onsite at USA - NC - Durham - Hamlin Rd. Night shift from 7 PM to 7 AM on a 2-2-3 schedule, including overnight 12-hour shifts.

Company

hirify.global operates biotechnology manufacturing facilities supporting early- and late-phase cell culture programs.

What you will do

• Manufacture cell culture products according to batch records, SOPs, company policies, and applicable regulations.
• Perform upstream or downstream unit operations, including media and buffer preparation, bioreactor operations, chromatography, ultrafiltration, and drug substance filling.
• Conduct cleanroom operations, including gowning, cleaning, and aseptic processing controls.
• Complete manufacturing documentation, including SRs, EPRs, and BRs, in accordance with Good Documentation Practices.
• Operate and maintain production equipment, including single-use bioreactors, chromatography skids, ultrafiltration skids, filling systems, pumps, and analytical equipment.
• Maintain process ownership, equipment and facility standards, item accountability, and 5S practices.

Requirements

• Manufacturing Associate I: bachelor’s degree in a related scientific or engineering discipline and 0–2 years of GMP manufacturing experience, or high school diploma and 3–5 years of related GMP manufacturing experience.
• Manufacturing Associate II: bachelor’s degree in a related scientific or engineering discipline and 2–5 years of GMP manufacturing experience, or high school diploma and 4–6 years of related GMP manufacturing experience.
• Fluent English reading, writing, speaking, and comprehension is required.
• Basic understanding of cell culture, fermentation, or purification unit operations.
• Ability to work in a cGMP cleanroom environment, follow SOPs, interpret manufacturing records, and maintain accurate documentation.
• Ability to stand and walk throughout the facility, lift and carry 20 kg bags, push 200 kg drums, use ladders or step stools, and work around mechanical, chemical, electrical, noise, and trip hazards.

Culture & Benefits

• Fast-paced, multitasking biotechnology manufacturing environment.
• Work follows a 2-2-3 night-shift schedule with 12-hour shifts.
• Cleanroom attire and strict personal hygiene practices are required.
• Work includes collaboration over radios, phones, and in production areas with moderate to high noise levels.