Senior Manufacturing Associate I/II - Purification (Days, 6am-6pm)

Location: USA - NC - Durham - National Way; onsite work in a cGMP cleanroom facility on 12-hour day shifts from 6am to 6pm, following a 2-2-3 rotating schedule.

Company

hirify.global provides biopharmaceutical manufacturing operations and support for bulk intermediates and drug substances.

What you will do

• Manufacture bulk intermediates and drug substances according to batch records, SOPs, GMP requirements, and current regulations.
• Perform downstream purification operations including chromatography, tangential flow filtration, viral inactivation, and bulk filling.
• Conduct cleanroom and aseptic processing activities, including gowning, cleaning, equipment setup, and material control.
• Operate and maintain bioprocessing equipment such as mixing vessels, filters, pumps, balances, pH and conductivity meters, and single-use technologies.
• Document manufacturing activities and logbooks in real time according to good documentation practices.
• Guide Manufacturing Associates, support workload distribution, troubleshoot operations, and collaborate with QA, MS&T, facilities, engineering, supply chain, IT, and other groups.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline plus 4–6 years of related GMP manufacturing experience for level I, or 5+ years for level II.
• Alternatively, a high school diploma plus 7–10 years of related GMP manufacturing experience for level I, or 10+ years for level II.
• Fluent reading, writing, and speaking English, with the ability to interpret safety rules, procedures, and batch production records.
• Knowledge of upstream or downstream bioprocessing operations, including purification and bulk filling.
• Ability to work in a cleanroom, wear required cleanroom attire, follow hygiene procedures, and work 12-hour shifts that may include overnight work.
• Ability to stand or sit for extended periods and lift, push, pull, or use ladders when handling equipment and bioreactors.

Nice to have

• Experience with single-use platform technology.
• Experience with upstream cell culture or fermentation operations.

Culture & Benefits

• Work in a regulated biopharmaceutical manufacturing environment focused on right-first-time execution and continuous improvement.
• Follow cGMP, GLP, 5S workplace organization, and quality-system practices.
• Collaborate cross-functionally to support reliable, compliant startup and ongoing manufacturing operations.
• Employment with an EEO/AA employer committed to workforce diversity.