Associate Manufacturing- (Bulk Drug Substance - Services)- NightShift

About the role

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX Batch facility combines the latest in disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. This facility features best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and integrates sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon-neutral company by 2027.

This is an essential position supporting 24/7 manufacturing operations on a 12-hour night shift (5:45pm to 6:15am) following a 2-2-3 schedule. Associates will perform operations on the manufacturing floor, responsible for producing cGMP (Current Good Manufacturing Practices) drug substances. Regular attendance is required, including during inclement weather, holidays, and requested overtime.

Responsibilities

• Complete work in accordance with established cGMP procedures and policies (SOPs, Manufacturing Procedures, Job Hazard Analysis, Code of Federal Regulations) with strict adherence to safety and compliance.
• Ensure proper gowning and aseptic techniques are always followed.
• Perform hands-on operations including set-up, cleaning, sanitization, and monitoring of equipment in assigned area.
• Run and monitor critical process tasks per assigned procedures.
• Prepare and transfer buffers and media; weigh and dispense materials for buffer and media preparation.
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records).
• Complete washroom activities, including cleaning small to large-scale production equipment.
• Identify and escalate issues related to daily routine functions; collaborate on potential solutions.
• Perform documentation for assigned functions (e.g., equipment logs, EBRs).
• Collaborate as part of a cross-functional team (QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, Regulatory) to complete production activities.
• Maintain an organized, clean, and workable space.

Requirements

• High School diploma or GED plus 2 years of manufacturing and/or other regulated environment experience, or
• Associate’s Degree plus 6 months of manufacturing and/or other regulated environment experience, or
• Bachelor’s Degree.

Qualifications

• Completion of NC BioWork Certificate Program.
• Experience in a regulated industry such as biotechnology or pharmaceuticals.
• Basic understanding and process experience in a cGMP manufacturing facility.
• Excellent verbal and written communication skills.
• Proficient in Microsoft Office and familiar with electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
• Demonstrated desire and drive to learn and grow understanding of operations and processes.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on relevant skills, experience, and qualifications.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program (or sales-based incentive plan for field sales representatives).
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements where possible.

No relocation assistance will be provided for this position.