Associate Manufacturing - Bulk Drug Substance Downstream - Days (Biotechnology)

Location: Holly Springs, North Carolina, United States. Onsite manufacturing role requiring Monday–Friday work during startup, followed by a 12-hour 2-2-3 schedule from 5:45 a.m. to 6:15 p.m. The role may require non-standard shifts, holidays, inclement-weather attendance, and overtime.

Salary: $70,985.20–$96,038.80 annually.

Company

hirify.global is a biotechnology company developing and manufacturing medicines, with this role supporting its advanced FleX Batch drug substance manufacturing facility.

What you will do

• Support operational readiness, facility startup, commissioning, qualification, and ramp-up activities.
• Perform downstream purification operations, including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill.
• Set up, operate, monitor, clean, and sanitize manufacturing equipment and assigned areas.
• Perform in-process sampling, operate analytical equipment, and complete Electronic Batch Records.
• Execute manufacturing activities in accordance with cGMP procedures, SOPs, manufacturing procedures, job hazard analyses, and applicable regulations.
• Document deviations and quality events, support investigations and corrective actions, and escalate safety, quality, and operational issues.

Requirements

• High school diploma or GED plus 2 years of manufacturing or regulated-environment experience, or an associate degree plus 6 months of relevant experience, or a bachelor’s degree.
• Experience or understanding of cGMP manufacturing in biotechnology, pharmaceuticals, or another regulated industry is preferred.
• Ability to follow gowning and aseptic techniques and maintain a safe, clean, compliant manufacturing environment.
• Ability to work effectively in a team-based manufacturing environment and support assigned 12-hour shifts.
• Strong verbal and written communication skills and proficiency with Microsoft Office.
• Knowledge of EBR/MES, DeltaV, and electronic quality systems is preferred.

Nice to have

• Completion of the NC BioWorks Certification Program.
• Demonstrated motivation to learn and develop knowledge of manufacturing operations and processes.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus and stock-based long-term incentives.
• Paid time off and biannual company-wide shutdowns.
• Career development opportunities and flexible work models where applicable.