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

Location: Holly Springs, North Carolina, United States; onsite manufacturing role

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

Company

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

What you will do

• Support the ANC2 facility expansion, startup, commissioning, qualification, and transition to routine manufacturing operations.
• Perform weigh-and-dispense, material receiving and handling, media and buffer preparation, solution preparation, component preparation, parts washing, and autoclave operations.
• Set up, clean, sanitize, monitor, and operate manufacturing equipment and assigned production areas.
• Perform in-process sampling, operate analytical equipment, complete electronic batch records, and review equipment and process documentation.
• Coordinate daily Services activities, support staff training and qualification, coach personnel, and collaborate with QA/QC, Facilities & Engineering, manufacturing, process development, PPIC, and Regulatory functions.
• Identify operational issues, initiate deviations, support CAPAs and continuous improvement, and prepare or revise SOPs, manufacturing procedures, and technical reports.

Requirements

• High school diploma/GED with 4 years of manufacturing or regulated-environment experience; or an associate’s degree with 2 years of experience; or a bachelor’s degree with 6 months of experience; or a master’s degree.
• Experience working in accordance with cGMP procedures, safety requirements, SOPs, manufacturing procedures, and applicable regulations.
• Ability to perform hands-on manufacturing activities, follow gowning and aseptic techniques, complete documentation, and work safely in a controlled production environment.
• Ability to work the assigned schedule, including a future 12-hour 2-2-3 shift from 5:45 a.m. to 6:15 p.m., holidays, inclement weather, and requested overtime.
• Technical verbal and written communication skills and proficiency with Microsoft Office and electronic systems such as EBR/MES, DeltaV, and electronic quality systems.

Nice to have

• NC BioWorks Certification Program completion.
• Biotechnology or pharmaceutical plant startup experience.
• Experience in a cGMP manufacturing facility or another highly regulated environment.
• Knowledge of solution preparation, equipment preparation, and inventory control operations.

Culture & Benefits

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