Senior Associate - Bulk Drug Substance Manufacturing Services - Days (Biotech)

Location: Holly Springs, North Carolina, United States. 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.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses.

What you will do

• Support the ANC2 facility expansion, startup, commissioning, qualification, and ramp-up of manufacturing operations.
• Perform material receiving and handling, weighing and dispensing, media and buffer preparation, solution preparation, component preparation, parts washing, and autoclave operations.
• Operate, clean, sanitize, and monitor manufacturing equipment and assigned areas, including in-process sampling and analytical equipment operation.
• Coordinate daily Services activities, support staff training and qualification, and provide operational oversight and coaching.
• Complete electronic batch records, equipment logs, SOPs, manufacturing procedures, technical reports, deviation reports, and CAPA activities.
• Collaborate with QA/QC, Facilities and Engineering, PPIC, Manufacturing, Process Development, and Regulatory teams to ensure safe, compliant, and reliable production.

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.
• Experience working in accordance with cGMP procedures, safety requirements, SOPs, manufacturing procedures, and applicable regulations.
• Ability to work assigned 12-hour shifts, including some holidays, overtime, and during inclement weather.
• Knowledge of solution preparation, equipment preparation, inventory control, documentation, and regulated manufacturing operations.
• Technical verbal and written communication skills and proficiency with Microsoft Office and electronic manufacturing or quality systems.

Nice to have

• NC BioWorks Certification Program completion.
• Biotechnology or pharmaceutical plant startup experience.
• Experience with 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.
• Annual bonus program and stock-based long-term incentives.
• Paid time off, biannual company-wide shutdowns, and career development opportunities.
• Flexible work models where applicable.