Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Night Shift

Role: Manufacturing Manager (Downstream) for night shift at Amgen's advanced biologics production facility, overseeing GMP manufacturing of drug substances. Responsibilities: lead and develop on-shift teams, ensure safety, cGMP compliance, and operational excellence; manage process execution, equipment, and technical troubleshooting; foster a culture of continuous improvement and Lean principles; collaborate with cross-functional teams including QA, QC, engineering, and regulatory; support process optimization and problem resolution; develop staffing, training, and mentorship initiatives. Qualifications: Doctorate or Master’s degree with 3+ years, Bachelor’s with 5+ years, or equivalent experience in biotech manufacturing; previous management experience in a GMP environment; strong leadership, technical understanding of downstream processes (chromatography, TFF, viral filtration), and regulatory compliance; excellent communication and computer skills. Preferred: background in biotech or pharma startup, 5+ years process experience, knowledge of viral inactivation, and experience with manufacturing systems like MES and Delta V. HighValue: biologics (likely monoclonal antibodies), downstream purification, cGMP, 24/7 GMP production, team leadership, process optimization, regulatory interaction. WorkSetup: night shift (12-hour rotation), onsite at new facility with advanced disposables and Industry 4.0 capabilities.