Manufacturing Associate I/II (Biopharmaceutical Manufacturing)

Location: USA - NC - Durham - National Way; onsite work in a cGMP biotechnology manufacturing facility. The position follows a 2-2-3 day shift schedule from 6:00 a.m. to 6:00 p.m.; 12-hour shifts may include overnight work.

Company

hirify.global develops and manufactures biopharmaceutical products through regulated biotechnology manufacturing operations.

What you will do

• Manufacture bulk intermediates and drug substances according to manufacturing batch records, quality standards, company policies, and applicable regulations.
• Execute upstream unit operations, including seed expansion, bioreactor operations, and cell culture harvest.
• Perform aseptic processing in cleanrooms, including gowning, cleaning, equipment setup, and material handling.
• Document manufacturing activities in batch records and logbooks following good documentation practices at the time of execution.
• Operate and maintain upstream, general production, and in-process testing equipment according to applicable SOPs.
• Review production records and logbooks for GxP compliance and collaborate with QA, MS&T, facilities, engineering, supply chain, IT, and other departments.

Requirements

• Manufacturing Associate I: bachelor's degree in a related scientific or engineering discipline with 0–2 years of related cGMP manufacturing experience, or a high school diploma with 3–5 years of experience, or equivalent.
• Manufacturing Associate II: bachelor's degree in a related scientific or engineering discipline with 2–5 years of related cGMP manufacturing experience, or a high school diploma with 4–6 years of experience, or equivalent.
• Basic knowledge of upstream cell culture or fermentation unit operations and strong written and verbal communication skills.
• Fluent English reading and writing skills, including the ability to interpret safety rules, SOPs, operating instructions, and batch production records.
• Ability to work in a cleanroom, wear required cleanroom attire, maintain personal hygiene, and perform 12-hour shifts.
• Ability to stand or sit for extended periods and lift, push, pull, and use ladders when setting up bioreactors.

Nice to have

• Experience with single-use platform technology.
• Experience with upstream or downstream bioprocessing equipment and in-process testing instruments.
• Experience with MS Office, ERP, EDMS, or production equipment software.

Culture & Benefits

• Work in a regulated cGMP biotechnology manufacturing environment.
• Participate in cross-functional manufacturing startup and ongoing operations.
• Support workplace organization through 5S practices.
• Work around mechanical, chemical, electrical, and trip-and-fall hazards in a moderate-to-high noise environment.