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

Location: Holly Springs, North Carolina, United States; onsite manufacturing role. The role initially follows a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule and transitions to a 12-hour 2-2-3 schedule from 5:45 a.m. to 6:15 p.m., including occasional holidays, overtime, and work during inclement weather.

Salary: $86,048.05–$116,417.95 per year.

Company

hirify.global is a biotechnology company developing treatments and operating advanced drug substance manufacturing facilities.

What you will do

• Support operational readiness, commissioning, qualification, facility startup, and manufacturing ramp-up.
• Execute downstream purification operations, including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill.
• Prepare, clean, sanitize, monitor, and operate manufacturing equipment and perform in-process sampling.
• Complete electronic batch records, equipment documentation, SOPs, manufacturing procedures, and technical reports.
• Initiate and support investigations, quality observations, CAPAs, and continuous improvement initiatives.
• Collaborate with QA/QC, Facilities and Engineering, Production Planning, Process Development, Manufacturing, and Regulatory teams.

Requirements

• High school diploma/GED plus 4 years of manufacturing or regulated-environment experience; or an associate degree plus 2 years; or a bachelor’s degree plus 6 months; or a master’s degree.
• Knowledge or experience in cGMP manufacturing or another highly regulated environment.
• Ability to work assigned 12-hour shifts, including holidays, overtime, and during inclement weather when required.
• Ability to follow safety, compliance, gowning, and aseptic-processing procedures.
• Technical communication skills and proficiency with Microsoft Office and electronic manufacturing systems.
• Experience with EBR/MES, DeltaV, and electronic quality systems is preferred.

Nice to have

• NC BioWorks Certification Program completion.
• Biotechnology or pharmaceutical plant startup experience.
• Experience with downstream purification operations.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off and bi-annual company-wide shutdowns.
• Career development and professional growth opportunities.