Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

BioSpace; Holly Springs (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking a Front Line Manufacturing Manager - Upstream Bulk Drug Substance in North Carolina to lead an expanding facility startup and ramp to 24/7 operations. You will oversee a cell culture manufacturing team, drive readiness, and coordinate across Quality, Engineering, and NPI to ensure compliant, efficient production.

The role requires a strong background in cGMP manufacturing, technology transfer, and people leadership, with Monday–Friday start and eventual 12-hour shifts.

Qualifications

• Doctorate degree or Masters degree with manufacturing/operations experience, or Bachelors with experience, or Associates with 10 years in manufacturing/operations, or High School with 12 years in manufacturing/operations.
• AND Previous managerial experience directly managing people and/or leading teams, projects, programs or directing resources.

Responsibilities

• Lead, develop, and coach a manufacturing team to meet safety, quality, schedule, and cost goals.
• Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new facility.
• Ensure safe, cGMP-compliant execution and drive performance across safety, quality, schedule, and cost.
• Support transfer and implementation of manufacturing processes; ensure manufacturability and troubleshooting.
• Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership for startup and rampup.
• Maintain inspection readiness and adherence to regulatory and Amgen quality standards.
• Identify and drive efficiency, reliability, and scalability improvements as operations mature.
• Work nonstandard hours as required, transitioning to a 12-hour shift for 24/7 operations.

Skills

People management

cGMP

Manufacturing operations

Technology transfer

Regulatory compliance

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Tools

MES/EBR

DeltaV

Maximo

Veeva

LIMS

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens 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 Amgens plan to be a carbon-neutral company by 2027.

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

What you will do

Letsdo this. Letschange the world. Amgen is seeking a Manager ManufacturingUpstream to provide frontline leadership supporting the facility expansion program and facility startup. Thisessentialrole will lead a team responsible for manufacturingcell cultureoperationsincluding seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup 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 thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm.

This role may require work outside standard business hours, including nonstandard 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 positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting 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-hourshift, 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, cGMPcompliant 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.
• CrossFunctional Collaboration: Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and rampup.
• 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 nonstandard hours as required, transitioning to a 12hour 223 dayshift supporting 24/7 operations.

What we expect from you

We are all different, yet we all use our unique contributions to serve patients. Thebiotechnologyprofessional weseekis amanagerwith these qualifications.

Basic Qualifications

• Doctoratedegree OR
• Masters degreeand3years ofManufacturing or Operationsexperience OR
• Bachelors degree and5years ofManufacturing or Operationsexperience OR
• Associates degree and 10 years of ManufacturingorOperations experience OR
• High school diploma / GED and 12 years of ManufacturingorOperations experience
• AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Bachelors 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 conflictresolution skills
• Solid understanding of regulatory requirements
• Proficiencywith MES/EBR,DeltaV, Maximo, Veeva, LIMS, and electronic quality systems

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 Plancomprisinghealth 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

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