Front Line Manufacturing Manager - Bulk Drug Substance Services

About the role

Amgen is seeking a Front Line Manufacturing Manager for its new bulk drug substance manufacturing facility, the FleX Batch plant, which combines disposable technologies with stainless steel equipment and includes Industry 4.0 and sustainability features. The role provides frontline leadership for the facility expansion and startup, leading a team covering Raw Material and Solution Logistics, Weighing and Dispensing, Buffer/Media Solution Preparation, Parts Washer, Autoclave and material handling, and partnering with Quality, Engineering, NPI, Supply Chain, Validation and Site Leadership. The position starts with startup and operational readiness, then transitions to manufacturing leadership.

Key responsibilities

• Lead, develop and coach a manufacturing team, set performance expectations and foster a culture of safety, quality and accountability
• Support design, build, commissioning, qualification (C&Q), staffing, training and readiness milestones of the new facility
• Ensure safe, cGMP-compliant execution and drive performance on safety, quality, schedule and cost, resolving deviations and operational issues
• Support technology transfer and process implementation, troubleshooting and continuous improvement
• Maintain inspection readiness and adherence to regulatory and Amgen quality standards
• Work non-standard hours, including a Monday-Friday 8am-5pm schedule initially, then a 12-hour 2-2-3 shift (5:45am-6:15pm) supporting 24/7 operations, including overtime and holidays

Required profile

• Doctorate or Master's degree with 3 years of manufacturing or operations experience, or Bachelor's degree with 5 years, or Associate's degree with 10 years, or high school diploma with 12 years
• Previous managerial experience directly managing people and/or leading teams, projects or programs
• Preferred: Bachelor's degree in Life Sciences or Engineering, biologics/drug substance manufacturing experience, cGMP experience (5+ years preferred), experience with facility startup, commissioning, technology transfer and process implementation, prior area lead/specialist/manager experience, strong leadership and conflict-resolution skills, solid understanding of regulatory requirements

Required skills

• Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS and electronic quality systems (preferred)

What we offer

• Annual base salary range of $106,148 to $143,612 USD
• Total rewards: health, dental and vision coverage, life and disability insurance, flexible spending accounts, retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Award-winning time-off plans, bi-annual company-wide shutdowns, and flexible work models including remote work where possible