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

How might you defy imagination? You've worked hard to become the professional you are today and are now ready to take the next step in your career. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful 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 not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

About the role

As a non-shift front line manager in manufacturing, you will oversee teams of manufacturing associates with differing levels of experience responsible for the manufacture of GMP drug substances. The working schedule is based on a day or night shift (12-hour) rotation. This essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45am to 6:15pm. Through structured on-the-floor presence, you will champion a safe and compliant production environment. As an active participant and role model in a Lean and continuous improvement culture, the manager will embed these principles onto the manufacturing floor.

Responsibilities

• Oversee teams in technical, on-the-floor operations in a biotechnology production operation.
• Support the development of your staff through coaching, hiring, and mentorship.
• Assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering short- and long-term Amgen Operational goals.

Compliance

• Ensure a safe working environment.
• Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas.
• Evaluate current operating procedures and recommend changes to management to optimize production.
• Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the 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 in optimizing organizational structure and responsibilities.
• Ensure plant safety through auditing, evaluations, and cross-functional walks.
• Ensure gowning and aseptic techniques training programs are maintained.

Process/Equipment/Facilities

• Demonstrate technical mastery of manufacturing processes.
• Collaborate with cross-functional teams (i.e., QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.) in completing production activities.
• Develop, implement, and assess CAPAs and solutions to complex problems.
• Responsible for elevating and resolving problems during daily operations.
• Oversee set up, 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.

Qualifications

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 operation (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, Electronic quality systems.

Benefits

The annual base salary range for this opportunity in the U.S. is provided below. In addition to the base salary, 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.
• A 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.