Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

Location: Holly Springs, North Carolina, United States. The role requires onsite work, initially Monday–Friday from 8:00 a.m. to 5:00 p.m., transitioning to a 12-hour 2-2-3 schedule from 5:45 a.m. to 6:15 p.m. The position may require nonstandard shifts, holidays, inclement-weather attendance, and overtime.

Company

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

What you will do

• Support operational readiness, facility expansion, commissioning, qualification, and startup activities for a new drug substance manufacturing facility.
• Perform upstream cell culture operations, including seed train, single-use and stainless-steel bioreactors, perfusion, harvest, depth filtration, and centrifugation.
• Set up, clean, sanitize, monitor, and operate production equipment while completing in-process sampling and electronic batch records.
• Execute procedures and workflows in accordance with cGMP, safety, and regulatory requirements.
• Identify quality observations, support investigations and CAPAs, and escalate operational or safety concerns.
• Collaborate with QA/QC, Facilities and Engineering, Production Planning, Manufacturing, Process Development, and Regulatory teams.

Requirements

• High school diploma or 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.
• Experience in biotechnology, pharmaceuticals, manufacturing startup, or another highly regulated environment.
• Knowledge of cGMP manufacturing, aseptic techniques, safety procedures, and controlled documentation.
• Working knowledge of upstream operations such as vial thaw, inoculation, cell expansion, single-use bioreactors, production bioreactors, ATF, harvest centrifuges, and depth filtration.
• Technical verbal and written communication skills and proficiency with Microsoft Office.
• Ability to work required onsite shifts, including 12-hour schedules, holidays, inclement weather, and requested overtime.

Nice to have

• NC BioWork Certificate Program completion.
• Experience with EBR/MES, DeltaV, and electronic quality systems.

Culture & Benefits

• Collaborative work with cross-functional manufacturing and technical teams.
• Competitive benefits and comprehensive total rewards aligned with local industry standards.
• Opportunity to support a facility using disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.
• Work focused on compliant, safe, and continuous-improvement-oriented manufacturing operations.