Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

Amgen seeks a Senior Associate Manufacturing for upstream bulk drug substance production at its North Carolina facility. This role executes cGMP manufacturing operations on a 12-hour shift schedule within a state-of-the-art biopharmaceutical manufacturing plant.

Responsibilities

• Execute on-the-floor upstream manufacturing operations in compliance with cGMP procedures and regulations
• Perform equipment setup, cleaning, sanitization, in-process sampling, and batch documentation
• Initiate quality observations and support investigations into deviations and discrepancies
• Collaborate cross-functionally with quality assurance, engineering, and process development teams
• Identify and recommend process improvements and implement corrective actions

Requirements

• High school diploma/GED plus 4 years manufacturing or regulated environment experience
• Associate's degree plus 2 years manufacturing or regulated environment experience
• Bachelor's degree plus 6 months manufacturing or regulated environment experience
• Knowledge of cGMP practices and upstream bioprocess operations
• Strong verbal and written communication skills
• Proficiency with Microsoft Office and electronic batch record systems