Senior Manufacturing Associate II (Biopharma)

Location: USA - NC - Durham - National Way; onsite cleanroom manufacturing facility

Company

hirify.global develops and manufactures biopharmaceutical products and bulk drug substances.

What you will do

• Manufacture bulk intermediates and drug substances according to batch records, SOPs, cGMP requirements, and current regulations.
• Perform upstream, downstream, and manufacturing support operations, including cell culture, bioreactor processing, chromatography, tangential flow filtration, viral inactivation, bulk filling, solution preparation, parts washing, and autoclaving.
• Operate, maintain, troubleshoot, commission, and qualify bioprocessing and production equipment.
• Document manufacturing activities, materials, logbooks, deviations, and records according to good documentation practices.
• Author or support SOPs, Master Batch Records, and CAPAs, and contribute to continuous improvement and startup activities.
• Provide direction to Manufacturing Associates and collaborate with QA, MS&T, facilities, engineering, supply chain, IT, and other support functions.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline and 5+ years of related GMP manufacturing experience, or a high school diploma and 10+ years of related GMP manufacturing experience.
• Experience or working knowledge of upstream or downstream bioprocessing equipment and 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 written and oral instructions, calculate rates and percentages, and interpret graphs.
• Ability to work in a cleanroom environment, follow gowning and hygiene procedures, and perform physical tasks including standing, lifting, pushing, pulling, and occasional ladder use.
• Availability for 12-hour dayshift rotations from 6 AM to 6 PM on a 2-2-3 schedule, with possible overnight work.

Nice to have

• Knowledge of cell culture, fermentation, purification, or bulk filling operations.
• Experience with single-use platform technology.
• Proficiency with MS Office, ERP, EDMS, and production equipment software.

Culture & Benefits

• Work in a cGMP biotechnology manufacturing facility with cleanroom operations.
• Collaborate cross-functionally to maintain reliable, compliant, and schedule-adherent manufacturing operations.
• Follow workplace organization practices based on 5S.
• Operate in an environment with mechanical, chemical, electrical, and trip-and-fall hazards and moderate-to-high noise levels.