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

Location: Holly Springs, North Carolina, United States. The role requires onsite manufacturing work, including a Monday–Friday 8:00 a.m.–5:00 p.m. startup schedule followed by a 12-hour 2-2-3 shift from 5:45 a.m. to 6:15 p.m., including some holidays, inclement weather, and overtime.

Company

hirify.global is a biotechnology company developing and manufacturing medicines, with the Holly Springs facility designed for flexible drug substance manufacturing using disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.

What you will do

• Support facility expansion, operational readiness, commissioning, qualification, startup, and manufacturing ramp-up.
• Perform downstream purification operations, including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill.
• Set up, clean, sanitize, monitor, and operate manufacturing equipment and critical processes.
• Perform in-process sampling, operate analytical equipment, complete electronic batch records, and review equipment and production documentation.
• Identify operational issues, support deviations, investigations, CAPAs, and process improvements.
• Collaborate with QA/QC, Facilities & Engineering, Production Planning, Manufacturing, Process Development, and Regulatory teams.

Requirements

• High school diploma/GED and 4 years of manufacturing or regulated-environment experience; or an associate degree and 2 years of experience; or a bachelor's degree and 6 months of experience; or a master's degree.
• Experience working in accordance with cGMP procedures, safety requirements, SOPs, manufacturing procedures, and regulatory standards.
• Ability to perform hands-on aseptic manufacturing work and maintain accurate process documentation.
• Ability to work assigned 12-hour shifts, including holidays, inclement weather, and requested overtime.
• Technical verbal and written communication skills and proficiency with Microsoft Office and electronic manufacturing systems.

Nice to have

• NC BioWorks Certification Program completion.
• Biotechnology or pharmaceutical plant startup experience.
• Experience with downstream purification, including column chromatography, TFF, viral filtration, and viral inactivation.
• Knowledge of EBR/MES, DeltaV, and electronic quality systems.

Culture & Benefits

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