Front Line Manufacturing Manager - Bulk Drug Substance Services - Days

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Flexible work arrangements

Job summary

Amgen in North Carolina seeks a Front Line Manufacturing Manager for Bulk Drug Substance Services to provide frontline leadership for the facility expansion, startup, and ongoing operations. You will oversee teams handling materials, weighing, buffer/media prep, parts washers, and autoclave processes to ensure readiness and compliant production.

The role covers startup, technology transfer, and ramp-up with a 12-hour 2-2-3 shift during 24/7 operations; occasional nonstandard hours and holidays

Qualifications

• Doctorate degree OR
• Masters degree and 3 years of Manufacturing or Operations experience OR
• Bachelor's degree and 5 years of Manufacturing or Operations experience OR
• Associates 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

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.
• 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 2-2-3 dayshift supporting 24/7 operations.

Skills

Leadership

People management

Project management

Quality systems

Regulatory compliance

Communication

Problem solving

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate degree

High school diploma

Tools

MES/EBR

DeltaV

Maximo

Veeva

LIMS

Job description

HOW MIGHTYOUDEFY IMAGINATION?

Youveworked 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over10 million patientsworldwide. 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. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Front Line Manufacturing Manager - Bulk Drug Substance Services - Days

What youwill do

Letsdo this.Letschange the world.Amgen is seeking aManagerManufacturingServicesto provide frontline leadership supporting the facility expansion program and facility startup. Thisessentialrole will lead a team responsible for manufacturingoperationsincludingRaw Material and Solution Logistics, Weighing and Dispensing, Buffer/Media Solution Preparation, Parts Washer, and Autoclave, and material handling,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:Maintaininspection readiness and adherence to regulatory and Amgen quality standards.
• Continuous Improvement:Identifyand drive efficiency, reliability, and scalability improvements as operations mature.
• Shift Support:Work nonstandard hours asrequired, transitioning to a 12hour 223 dayshift supporting 24/7 operations.

Win

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 (Services)
• 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

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 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

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

careers.amgen.com

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