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

Responsibilities

• Oversee manufacturing associates responsible for the manufacture of GMP drug substances in a 24/7 biotechnology production environment.
• Champion a safe and compliant production environment through structured on-the-floor presence.
• Lead, recruit, train, and mentor staff to drive team performance and continuous improvement.
• Ensure adherence to cGMP, CFR, and corporate change control procedures.
• Manage technical on-the-floor operations, including the setup and execution of critical manufacturing processes.
• Collaborate with cross-functional teams such as QA/QC, Engineering, and Regulatory to resolve operational problems.
• Support the development of area objectives and implement CAPAs to solve complex technical issues.

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 and/or experience leading teams, projects, or programs.
• Ability to work a 12-hour night shift rotation (5:45pm to 6:15am) on a 2-2-3 schedule.

Preferred Qualifications

• Bachelor’s degree in Life Sciences or Engineering.
• Knowledge of downstream purification operations including Column Chromatography, TFF, and Viral Filtration.
• Experience in a cGMP manufacturing environment and biotechnology plant start-ups.
• Strong leadership skills with experience in performance management, coaching, and conflict resolution.
• Proficiency with Microsoft Office, EBR/MES, Delta V, and electronic quality systems.

Benefits

• Comprehensive health and welfare plans including medical, dental, and vision.
• 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 develops innovative human therapeutics to improve health outcomes worldwide.