Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Amgen; Holly Springs (NC); On-site; USD 106,000 - 144,000; Full time

Benefits offered by this job

Flexible work models

Stock-based incentives

Retirement and savings plan

Job summary

Amgen Inc. in North Carolina seeks a Front Line Manufacturing Manager for Upstream Bulk Drug Substance. The role leads a manufacturing team through startup, readiness, and 24/7 operations, coordinating with Quality, Engineering, and Supply Chain to ensure safe, compliant, and efficient production.

The position requires advanced degrees or extensive manufacturing experience, strong leadership, and the ability to work a 12‑hour shift during startup and 24/7 operations as needed.

Qualifications

• Managerial experience directly leading people and teams.
• Experience with facility startup, commissioning, or operational readiness.
• Biologics/drug substance manufacturing experience (Upstream) preferred.
• cGMP manufacturing experience (5+ years preferred).

Responsibilities

• Frontline leadership: lead, develop, coach a manufacturing team with safety, quality, and accountability.
• Support design, build, commissioning, qualification, staffing, and readiness milestones for a new facility.
• Ensure safe, cgmp-compliant execution; drive performance across safety, schedule, and cost.
• Support technology transfer and process implementation; troubleshoot and improve.
• Collaborate cross-functionally with Quality, Engineering, Supply Chain, Validation, and Site Leadership.

Skills

Leadership

Safety culture

Quality compliance

Cross-functional collaboration

Problem solving

Team development

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

MES/EBR

DeltaV

Maximo

Veeva

LIMS

Job description

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen’s next generation drug substance manufacturing facility in North Carolina. We are starting up our first facility and breaking ground on our second facility. Both facilities feature the best in-class drug substance technologies and integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon-neutral company by 2027. If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Manager Manufacturing Upstream to provide frontline leadership supporting the facility expansion program and facility startup. This essential role will lead a team responsible for manufacturing cell culture operations including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation, while partnering across functions to ensure successful operational readiness, technology transfer, and ramp‑up of manufacturing operations within the new facility. The Manager will play a critical role supporting the design, build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational. During this phase of the startup, you will be expected to work a Monday – Friday schedule from 8am – 5pm. This role may require work outside standard business hours, including non‑standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. As the business moves from C&Q to manufacturing operations, this essential position will work on a 12-hour 2-2-3 schedule from 5:45 am to 6:15pm supporting our critical 24/7 manufacturing operations. As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our operations.

Responsibilities

• Frontline Leadership: Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability.
• Facility Startup & Operational Readiness: Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility.
• Manufacturing Operations: Ensure safe, cGMP‑compliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues.
• Technology Transfer & Process Implementation: Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement.
• Cross‑Functional Collaboration: Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp‑up.
• Compliance & Inspection Readiness: Maintain inspection readiness and adherence to regulatory and Amgen quality standards.
• Continuous Improvement: Identify and drive efficiency, reliability, and scalability improvements as operations mature.
• Shift Support: Work non‑standard hours as required, transitioning to a 12‑hour 2‑2‑3 day shift supporting 24/7 operations.

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
• Bachelor’s degree and 5 years of Manufacturing or Operations experience
• Associate’s degree and 10 years of Manufacturing or Operations experience
• 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
• Experience with facility startup, commissioning, or operational readiness
• Biologics / drug substance manufacturing experience (Upstream)
• cGMP manufacturing experience (5+ years preferred)
• Experience with technology transfer and process implementation
• Prior Area Lead / Specialist / Manager experience
• Strong leadership, performance management, and conflict‑resolution skills
• Solid understanding of regulatory requirements
• Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and 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

Salary Range

106,148.00USD -143,612.00 USD

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen