Manufacturing Associate I (Biopharma)

Location: Durham, North Carolina, United States; onsite in a cleanroom environment. Dayshift is 6:00 AM–6:00 PM on a 2-2-3 rotating schedule, including weekends, nights, and holidays as required.

Company

hirify.global is a global contract development and manufacturing organization providing process development and biologics manufacturing services to life science companies.

What you will do

• Execute downstream purification of cell culture products through bulk fill using chromatography, filtration, and viral reduction techniques.
• Operate in a cleanroom while following gowning, cleaning, and aseptic processing procedures.
• Follow manufacturing records, standard operating procedures, and written instructions during production activities.
• Document work at the time of execution and review production records for GxP compliance.
• Operate and maintain equipment including chromatography systems, ultrafiltration/diafiltration systems, pumps, tubing welders and sealers, scales, and analytical tools.
• Account for materials and participate in room 5S activities.

Requirements

• High school diploma.
• Experience in a regulated industry or demonstrated knowledge of downstream or purification unit operations.
• Ability to follow written instructions and maintain a high level of attention to detail.
• Strong written and verbal communication, organization, and multitasking skills.
• Ability to work a 12-hour rotating schedule, including weekends, nights, and holidays.
• Understanding of current good manufacturing practices and their application to production activities.

Nice to have

• Associate or bachelor’s degree in a related scientific or engineering discipline.
• Biowork certification.
• Experience with single-use platform technology or work in a CDMO.

Culture & Benefits

• Work in a regulated GMP manufacturing environment supporting early- and late-phase biologics programs.
• Exposure to integrated drug development and biologics manufacturing processes.
• Inclusive workplace committed to equal opportunity and a diverse workforce.