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

About the role

Amgen is looking for a front-line manufacturing manager for its new FleX Batch drug substance manufacturing plant, which combines disposable technologies with stainless steel equipment and includes Industry 4.0 and sustainability features. The role is a 12-hour night shift (5:45pm to 6:15am) on a 2-2-3 rotation, supporting 24/7 operations. You will lead teams of manufacturing associates responsible for producing GMP drug substances, with structured on-the-floor presence and coaching, hiring and mentorship.

Key responsibilities

• Oversee teams in technical, on-the-floor operations and deliver short- and long-term operational goals
• Ensure safe working conditions, cGMP and CFR compliance, and proper gowning and aseptic techniques
• Evaluate operating procedures, follow change control, notify Regulatory and QA of changes, and interact with regulatory agencies as needed
• Recruit, train, evaluate, coach and mentor staff, and run training programs
• Ensure adherence to production schedules and maintenance activities, and audit plant safety
• Work with QA/QC, F&E, PPIC, Mfg, PD and Regulatory teams, and develop CAPAs
• Help define area objectives, identify improvements and manage budgets and department goals

Required profile

• Doctorate or Master's degree with 3 years of manufacturing or operations experience, or Bachelor's with 5 years, or Associate's with 10 years, or high school diploma with 12 years
• Previous managerial experience leading people, teams, projects or allocating resources
• Preferred: Bachelor's in Life Sciences or Engineering, biotech/pharma plant start-up experience, and 5+ years of cGMP process experience

Required skills

• Preferred: understanding of downstream purification (column chromatography, TFF, viral filtration/inactivation)
• Preferred: knowledge of cGMP environments and performance management
• Preferred: Microsoft, EBR/MES, Delta V and electronic quality systems

What we offer

• Annual base salary of $106,148 to $143,612
• Health, dental, vision, life and disability insurance, retirement savings plan and flexible spending accounts
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Time-off plans, bi-annual shutdowns and flexible work models where possible