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

Amgen; Holly Springs (NC); Hybrid; USD 130,000 - 180,000; Full time

Benefits offered by this job

Flexible work model

Career development opportunities

Competitive benefits

Job summary

Amgen seeks a Manager Manufacturing (Downstream) for the Night Shift to lead on-shift teams in a 12-hour 2-2-3 schedule, supporting 24/7 GMP drug substance production. The role emphasizes safety, Lean practices, coaching staff, and regulatory compliance in a complex biotech plant.

You will partner with QA/QC, F&E, PPIC, and Regulatory to deliver operational goals, drive improvements, and develop talent in a fast-paced environment.

Qualifications

• Doctorate or higher with manufacturing/operations experience as specified in the posting.
• And/or Master’s/Bachelor’s with manufacturing or operations experience and resource leadership.
• Experience directing teams, projects or programs and allocating resources as a manager.
• Strong leadership, biotechnology production operations knowledge and regulatory familiarity.
• Experience in a cGMP environment and downstream purification context.
• 5+ years in a cGMP manufacturing facility; 3+ years in a lead/manager role.

Responsibilities

• Lead on-shift front line management for 24/7 operations on a 12-hour rotation.
• Coach, hire and mentor staff; drive Lean and continuous improvement culture.
• Ensure compliance with cGMP and CFR and maintain safe production environments.
• Oversee cross-functional collaboration with QA/QC, F&E, PPIC, Mfg, PD, Regulatory.
• Develop area objectives, identify improvement opportunities and lead change.

Skills

Manufacturing leadership

Lean manufacturing

cGMP knowledge

Problem solving

Regulatory knowledge

Education

Doctorate or PhD

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

Microsoft Office

DeltaV

EBR/MES

Electronic quality systems

Job description

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. How will you put your skills, experience, and passion to work toward your goals? 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 FleX Batch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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.

Manager Manufacturing (Downstream) - Night Shift

Live

What You Will Do

Let’s do this. Let’s change the world. In these vital and dynamic roles you will be an on-shift front line manager in manufacturing. The working schedule is based on a day or night shift (12-hour) rotation. The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am. As a manufacturing leader you will oversee teams of manufacturing associates with differing levels of experience who will be responsible for the manufacture of GMP drug substances. 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 imbed these principles onto the manufacturing floor. Through your leadership, you will oversee teams in technical, on the floor operations in a biotechnology production operation. In addition, you will support the development of your staff through coaching, hiring, and mentorship. Font-line Manager will 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 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 trainings plans and programs, to ensure staff are prepared and compliant
• Ensure adherence to production schedule and maintenance activities
• Interacts 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
• Oversees set up, execution, and completion of critical manufacturing processes/tasks

Administrative

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

What We Expect From You

We are all different, yet we all use our unique contributions to serve patients. The biotechnology professional we seek is a manager with these 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
• AND 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 teambuilding 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

Thrive

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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 including:

• 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

Objects in your future are closer than they appear. Join us.

careers.amgen.com