Manufacturing Associate I/II (Biopharma)

Location: Durham, North Carolina, USA; onsite in a cGMP manufacturing biotechnology facility. The role requires 12-hour shifts, including possible overnight work, on a 2-2-3 schedule.

Company

hirify.global operates in biopharmaceutical manufacturing.

What you will do

• Manufacture early- and late-phase cell culture products according to batch records, SOPs, company policies, and current regulations.
• Perform upstream or downstream unit operations, including media and buffer preparation, bioreactor operations, chromatography, ultrafiltration, and drug substance filling.
• Conduct cleanroom and aseptic processing activities, including gowning, cleaning, and equipment setup.
• Complete manufacturing documentation, including SRs, EPRs, and BRs, according to Good Documentation Practices.
• Operate and maintain production equipment, maintain 5S standards, and support facility upkeep.
• Review documentation and maintain item accountability to ensure manufacturing and quality compliance.

Requirements

• 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.
• Fluent English reading, writing, speaking, and listening skills are required.
• Ability to interpret procedures, batch records, safety rules, operating instructions, and production schedules, and to write routine reports.
• Ability to work in cleanrooms, wear cleanroom attire, maintain personal hygiene, and follow cGMP, GDP, and GLP standards.
• Ability to stand and walk throughout production areas, work on ladders or step stools, reach around equipment, lift and carry 20 kg bags, and push 200 kg drums.

Nice to have

• Basic 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 in a fast-paced, multitasking biopharmaceutical manufacturing environment.
• Follow structured SOPs, batch records, quality standards, and current regulations.
• Work with biosafety cabinets, single-use bioreactors, chromatography and ultrafiltration skids, filling systems, pumps, analyzers, and laboratory equipment.
• Work around mechanical, chemical, electrical, trip, and fall hazards in a moderate- to high-noise environment.
• Maintain an organized, efficient, and positive approach during production activities.