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

Location: Holly Springs, North Carolina, United States. Onsite role requiring Monday–Friday work during startup, followed by a 12-hour 2-2-3 shift schedule from 5:45 a.m. to 6:15 p.m.; occasional holidays, overtime, and work during inclement weather may be required.

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

Company

hirify.global is a biotechnology company developing treatments and operating a new drug substance manufacturing facility with disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.

What you will do

• Support facility expansion, operational readiness, commissioning, qualification, and startup execution.
• Perform upstream cell culture operations including seed train, single-use bioreactors, perfusion, production bioreactors, depth filtration, and centrifugation.
• Set up, clean, sanitize, monitor, and operate manufacturing equipment according to approved procedures.
• Perform in-process sampling, operate analytical equipment, and complete electronic batch records and equipment documentation.
• Identify operational issues, support quality investigations and CAPAs, and implement process improvements.
• Collaborate with QA/QC, Facilities and 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.
• A bachelor’s degree with 6 months of manufacturing or regulated-environment experience, or a master’s degree.
• Ability to work assigned 12-hour shifts and support startup, commissioning, qualification, holidays, and overtime as needed.
• Knowledge of cGMP procedures, safety requirements, aseptic techniques, documentation, and regulated manufacturing practices.
• Technical communication skills and proficiency with Microsoft Office and electronic manufacturing or quality systems.

Nice to have

• NC BioWork Certificate Program completion.
• Biotechnology or pharmaceutical plant startup experience.
• Experience with upstream operations such as vial thaw, inoculation, cell expansion, single-use bioreactors, ATF, harvest centrifugation, and depth filtration.
• Knowledge of EBR/MES, DeltaV, and electronic quality systems.

Culture & Benefits

• Collaborative environment focused on serving patients and supporting professional growth.
• Competitive benefits and comprehensive total rewards aligned with local industry standards.
• Opportunity to work on a new advanced manufacturing facility with sustainability and industry 4.0 initiatives.