Manufacturing Associate II (Biopharma)

Location: USA - NC - Durham - Hamlin Rd; onsite manufacturing facility

Company

hirify.global provides biopharmaceutical 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 unit operations, including media and buffer preparation, bioreactor operations, chromatography, ultrafiltration, and drug substance filling.
• Execute cleanroom and aseptic processing activities, including gowning and cleaning procedures.
• Document procedures and manufacturing activities in SRs, EPRs, and BRs according to Good Documentation Practices.
• Operate and maintain manufacturing equipment according to applicable SOPs while upholding 5S standards.
• Review documentation, maintain process ownership, and ensure accountability for materials used in manufacturing records.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline with 2–5 years of GMP manufacturing experience, or a high school diploma with 4–6 years of related GMP manufacturing experience.
• Basic knowledge of cell culture, fermentation, or purification unit operations.
• Fluent English reading and writing skills are required, including the ability to interpret safety rules, SOPs, batch records, and production records.
• Strong written and verbal communication, organization, practical problem-solving, and mathematical skills.
• Ability to work onsite in a cGMP biotechnology facility and perform cleanroom operations.
• Availability for 12-hour shifts on a 2*2*3 schedule, potentially including overnight work.

Nice to have

• Experience with single-use platform technology.

Culture & Benefits

• Full-time employment in a regulated biopharmaceutical manufacturing environment.
• Work involves cleanroom attire, strict personal hygiene, and adherence to cGMP, GDP, and GLP standards.
• Regular standing and sitting, lifting, pushing, pulling, and occasional ladder use may be required.
• The environment may include mechanical, chemical, electrical, and trip-and-fall hazards with moderate to high noise levels.