Manufacturing Associate I / II (Biopharma Manufacturing)

Location: USA - NC - Durham - Hamlin Rd. Onsite work in a cGMP biotechnology manufacturing facility on 12-hour shifts, including a 7 AM–7 PM day shift and possible overnight work, following a 2-2-3 schedule.

Company

hirify.global provides biotechnology manufacturing services and develops cell culture production programs in a regulated GMP environment.

What you will do

• Manufacture early- and late-phase 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, aseptic processing, chromatography, ultrafiltration, and drug substance filling.
• Execute cleanroom activities, including gowning, cleaning, equipment setup, and adherence to aseptic processing controls.
• Document production activities in SRs, EPRs, and BRs according to Good Documentation Practices.
• Operate and maintain production equipment, including single-use bioreactors, chromatography skids, ultrafiltration skids, filling systems, pumps, and analytical instruments.
• Maintain process ownership, equipment and facility standards, 5S practices, material accountability, and production-record accuracy.

Requirements

• Manufacturing Associate I: Bachelor's degree in a related scientific or engineering discipline and 0–2 years of GMP manufacturing experience, or a 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 a high school diploma and 4–6 years of related GMP manufacturing experience.
• Fluent English reading, writing, speaking, and comprehension is required.
• Ability to interpret safety rules, operating instructions, procedure manuals, batch records, and production schedules and to prepare routine reports.
• Ability to solve practical problems, interpret varied instructions, perform basic mathematical calculations, and work efficiently in a fast-paced multitasking environment.
• Ability to stand and walk for extended periods, lift and carry 20 kg bags, push 200 kg drums, use ladders or step stools, and work around production equipment.

Nice to have

• Knowledge of cell culture, fermentation, or purification unit operations.
• Experience with single-use platform technology.
• Experience with MS Office, ERP, EDMS, and production equipment software.

Culture & Benefits

• Work takes place in a regulated cGMP biotechnology manufacturing facility with cleanroom operations.
• Required cleanroom attire and personal hygiene procedures apply in controlled areas.
• Work may involve mechanical, chemical, electrical, noise, tripping, and falling hazards.
• The role includes a 12-hour shift schedule, including possible overnight work.
• Production work requires communication over radios, phones, and machinery noise.