Associate Manufacturing - Bulk Drug Substance Downstream - Days

Responsibilities

• Support 24/7 manufacturing operations in the downstream area of a state-of-the-art drug substance manufacturing plant.
• Complete work in accordance with established cGMP procedures, including SOPs, Manufacturing Procedures, and Job Hazard Analysis.
• Perform hands-on downstream bio-tech operations such as Column Chromatography and Tangential Flow Filtration.
• Execute equipment set-up, cleaning, sanitization, and monitoring of assigned areas.
• Conduct in-process sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs).
• Initiate and own manufacturing-related process deviations and escalate technical concerns to the team.
• Collaborate with cross-functional teams including QA/QC, Engineering, and Process Development to complete production activities.
• Maintain strict adherence to safety, compliance, and aseptic gowning techniques.

Requirements

• High School/GED with 2 years of manufacturing or regulated environment experience, OR
• Associate’s Degree with 6 months of manufacturing or regulated environment experience, OR
• Bachelor’s Degree.
• Knowledge of cGMP practices.
• Proficiency in Microsoft Office.
• Ability to work a 12-hour 2-2-3 schedule (5:45am to 6:15pm), including holidays and overtime as needed.

Preferred Qualifications

• Completion of the NC BioWorks Certification Program.
• Previous experience in a regulated biotechnology or pharmaceutical industry.
• Basic understanding of process experience in a cGMP manufacturing facility.
• Experience with electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
• Strong verbal and written communication skills.

Benefits

• Comprehensive health, dental, and vision coverage.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.

About the Company

Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients suffering from serious illnesses. By leveraging advanced human genetics and biologics manufacturing expertise, Amgen discovers and delivers innovative human therapeutics to millions of patients worldwide.