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

About the role

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleXBatch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility features best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

This essential, non-shift front line manager position supports our critical 24/7 manufacturing operations on a 12-hour 2-2-3 night shift schedule from 5:45pm to 6:15am. As a manufacturing leader, you will oversee teams of manufacturing associates with differing levels of experience responsible for the manufacture of GMP drug substances.

Responsibilities

• Champion a safe and compliant production environment through structured on-the-floor presence.
• Embed Lean and continuous improvement principles onto the manufacturing floor as an active participant and role model.
• Oversee teams in technical, on-the-floor operations in a biotechnology production environment.
• Support staff development through coaching, hiring, and mentorship.
• Assist in defining area objectives, identifying improvement opportunities, and leading change efforts to deliver short- and long-term Amgen Operational goals.

Compliance

• Ensure a safe working environment and adherence to Amgen policies, including cGMP and CFR (Code of Federal Regulations) compliance.
• Evaluate current operating procedures and recommend changes to optimize production.
• Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to changes.
• Interact with regulatory agencies as needed.
• Assure proper gowning and aseptic techniques are followed.

Staff Supervision

• Engage staff and build relationships of trust and respect while driving team performance and continuous improvement.
• Recruit, train, evaluate, coach, and develop staff.
• Mentor and coach staff members to live by the Amgen Values.
• Develop and implement training plans and programs to ensure staff are prepared and compliant.
• Ensure adherence to production schedule and maintenance activities.
• Interact with management to optimize organizational structure and responsibilities.
• Ensure plant safety through auditing, evaluations, and cross-functional walks.
• Maintain gowning and aseptic techniques training programs.

Process/Equipment/Facilities

• Demonstrate technical mastery of manufacturing processes.
• Collaborate with cross-functional teams (e.g., QA/QC, F&E, PPIC, Mfg, PD, Regulatory) in completing production activities.
• Develop, implement, and assess CAPAs and solutions to complex problems.
• Elevate and resolve problems during daily operations.
• Oversee setup, execution, and completion of critical manufacturing processes/tasks.

Administrative

• Interact with management in planning, developing, and maintaining budget.
• Assist in developing and maintaining department goals.

Requirements

Basic Qualifications

• Doctorate degree, OR
• Master’s degree and 3 years of Manufacturing or Operations experience, OR
• Bachelor’s degree and 5 years of Manufacturing or Operations experience, OR
• Associate’s degree and 10 years of Manufacturing or Operations experience, OR
• High school diploma/GED and 12 years of Manufacturing or Operations experience.
• Previous managerial experience directly managing people and/or experience leading teams, projects, programs, or directing the allocation of resources.

Preferred Qualifications

• Bachelor’s degree in Life Sciences or Engineering.
• Demonstrated strong leadership skills and technical understanding of biotechnology production operations.
• Experience in biotechnology or pharmaceutical plant start-up.
• Understanding of downstream purification operations (Column Chromatography, TFF, Viral Filtration, Viral Inactivation).
• Previous knowledge and experience within a cGMP environment.
• 5+ years process experience in a cGMP manufacturing facility.
• 3+ years of experience in a production Area Lead, Specialist, or Manager role.
• Strong leadership and team-building skills (coaching, mentoring, counseling).
• Experience with performance management, including performance reviews.
• Conflict resolution, analytical problem-solving, and project management skills.
• Thorough understanding of regulatory requirements.
• Excellent verbal and written communication (technical) skills.
• Excellent computer skills with Microsoft, EBR/MES, Delta V, and Electronic quality systems.

Benefits

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements where possible.

Pay

The annual base salary range for this opportunity in the U.S. is provided below (specific range not stated in the posting).