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

Responsibilities

• Oversee manufacturing associates responsible for the manufacture of GMP drug substances in a 12-hour day shift rotation (2-2-3 schedule).
• Champion a safe and compliant production environment through structured on-the-floor presence and adherence to cGMP and CFR regulations.
• Recruit, train, coach, and mentor staff to drive team performance and continuous improvement.
• Manage technical on-the-floor operations, including the setup, execution, and completion of critical manufacturing processes.
• Collaborate with cross-functional teams such as QA/QC, Engineering, and Regulatory to resolve operational problems and implement CAPAs.
• Assist in defining area objectives, identifying improvement opportunities, and managing departmental budgets.

Requirements

• Doctorate degree OR Master’s degree + 3 years of Manufacturing/Operations experience OR Bachelor’s degree + 5 years of Manufacturing/Operations experience OR Associate’s degree + 10 years of Manufacturing/Operations experience OR High school diploma/GED + 12 years of Manufacturing/Operations experience.
• Previous managerial experience directly managing people or leading teams, projects, or programs.
• Knowledge of downstream purification processes.
• Experience working within a cGMP environment.
• Strong technical communication skills.

Preferred Qualifications

• Bachelor’s degree in Life Sciences or Engineering.
• Understanding of downstream purification operations (Column Chromatography, TFF, Viral Filtration, Viral Inactivation).
• Experience in biotechnology or pharmaceutical plant start-ups.
• 5+ years of process experience in a cGMP manufacturing facility.
• 3+ years of experience in a production Area Lead, Specialist, or Manager role.
• Proficiency with Microsoft Office, EBR/MES, Delta V, and electronic quality systems.

Benefits

• Comprehensive health and welfare plans, including medical, dental, and vision coverage.
• Retirement and Savings Plan with generous 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.