Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days

About this role

Career Category Manufacturing 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. When completed, the Amgen   FleX   Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The   FleX   Batch 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 - Downstream Bulk Drug Substance - Days  

What you   will do  

Let’s   do this.   Let’s   change the world .     Amgen is seeking a   Manager Manufacturing   Downstream   to provide frontline leadership supporting the facility expansion program and facility startup. This   essential   role will lead a team responsible for manufacturing   downstream purification operation s including column packing,   c olumn   c hromatography, TFF,   v iral   f iltration,   v iral   i nactivation , conjugation, and final fill   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.  

Win   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  

• Experience with facility startup, commissioning, or operational readiness  

• Biologics / drug substance manufacturing experience (downstream)  

• 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 comprisi

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