Manufacturing Associate I - Nights (Biotechnology)

Location: USA - NC - Durham - National Way; onsite night shift with 12-hour shifts from 7 PM to 7 AM on a 2-2-3 manufacturing schedule

Company

hirify.global provides biotechnology manufacturing services for early- and late-phase cell culture programs.

What you will do

• Manufacture cell culture products according to batch records, quality standards, company policies, and current regulations.
• Perform upstream or downstream production activities, including media and buffer preparation, bioreactor operations, chromatography, ultrafiltration, and drug substance filling.
• Conduct cleanroom operations, including gowning, cleaning, and aseptic processing controls.
• Document manufacturing activities in SRs, EPRs, and BRs in accordance with Good Documentation Practices.
• Issue and maintain accountability for materials used in manufacturing records.
• Operate and maintain equipment according to SOPs while upholding cGMP and 5S standards.

Requirements

• Bachelor's degree in a related scientific or engineering discipline with 0–2 years of GMP manufacturing experience, or a high school diploma with 3–5 years of related GMP manufacturing experience.
• Fluent English reading, writing, and speaking skills are required, including the ability to interpret safety rules, procedures, batch records, and production documents.
• Basic understanding of cell culture, fermentation, or purification unit operations.
• Ability to solve practical problems, interpret written and oral instructions, and perform basic mathematical calculations.
• Ability to work onsite in a cGMP manufacturing biotechnology facility, including cleanroom attire and overnight 12-hour shifts.
• Ability to stand and sit for extended periods and lift, push, pull, and use ladders when required for equipment setup.

Nice to have

• Experience with single-use platform technology.

Culture & Benefits

• Work in a fast-paced, multitasking manufacturing environment.
• Follow established quality, safety, hygiene, and documentation standards.
• Operate in an environment with mechanical, chemical, electrical, noise, and other workplace hazards.
• Full-time employment with a structured 2-2-3 shift schedule.