Downstream Manufacturing Associate I/ll (Biopharmaceutical Manufacturing)

Location: Durham, North Carolina, United States; onsite work in a cGMP biotechnology manufacturing facility. The role follows a 2-2-3 day-shift schedule from 7 a.m. to 7 p.m.; 12-hour shifts may occasionally include overnight work.

Company

hirify.global is a biopharmaceutical manufacturing company.

What you will do

• Manufacture bulk intermediates and drug substances according to manufacturing batch records, quality standards, company policies, and regulations.
• Perform upstream unit operations including seed expansion, bioreactor operations, and cell culture harvest.
• Execute aseptic processing in cleanrooms, including gowning and cleaning procedures.
• Document manufacturing activities and review production records and logbooks for GxP compliance.
• Operate and maintain bioprocessing, production, and in-process testing equipment according to SOPs.
• Collaborate with QA, MS&T, facilities, engineering, supply chain, IT, and other departments to support reliable manufacturing operations.

Requirements

• For Manufacturing Associate I: a related bachelor's degree with 0–2 years of relevant cGMP manufacturing experience, or a high school diploma with 3–5 years of experience, or equivalent.
• For Manufacturing Associate II: a related bachelor's degree with 2–5 years of relevant 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.
• Fluent English reading and writing skills, with the ability to interpret procedures, safety rules, maintenance instructions, and batch production records.
• Ability to solve practical problems, interpret varied instructions, perform basic mathematical calculations, and communicate effectively.
• Ability to work in cleanrooms, stand or sit for extended periods, and lift, push, pull, or use ladders when required.

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, and production equipment software.

Culture & Benefits

• Work is performed in a regulated cGMP biotechnology manufacturing environment.
• Responsibilities emphasize right-first-time execution, attention to detail, integrity, accountability, and ownership of production processes.
• Participation in workplace organization activities using 5S principles.
• The facility includes mechanical, chemical, electrical, noise, and trip-and-fall hazards; cleanroom attire and good personal hygiene are required.