Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)

Career Category

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 over10 million patients worldwide. Come do your bestwork 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 AmgenFleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleX 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. 

Senior Associate Manufacturing - New Product IntroductionSystems (Multiple Positions)

Live 

What youwill do 

Let’s do this.Let’s change the world. In this vital role, you will be a key member of the Manufacturing Support team at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This individual contributor will provide focused execution support for New Product Introduction (NPI) programs by coordinating cross-functional activities that enable compliant andtimely implementation. The role will primarilywork on Quality Risk Assessments,maintain associated Continuous Improvement records, create andmaintain process Bills of Materials, and own assigned Change Control records under the guidance of NPI management. The position interacts broadly with Manufacturing, Quality, Process Development, Supply Chain, Manufacturing Execution Systems (MES), and Single-Use Systems (SUS) to align requirements, track execution, andmaintain complete and inspection-ready documentation. 

Responsibilities: 

• Facilitate cross-functional Quality Risk Assessments (QRAs), including planning sessions, coordinating participants and source information, guiding structured risk discussions, documenting decisions, and supporting review and approval. 

• Prepare and maintain QRA reports, Failure Modes and Effects Analyses (FMEAs), risk action logs, and supporting recordsin accordance with applicable procedures and quality requirements. 

• Create andmaintain process Bills of Materials (BOMs) based on approved process and manufacturing requirements. 

• Coordinate BOM inputs, reviews, and reconciliation across Supply Chain, MES, SUS, Manufacturing, and other stakeholders to supportaccurate material readiness and alignment across systems and documents. 

• Own assigned NPI Change Control records under management guidance; prepare andmaintain record content, coordinate required impact assessments and implementation planning, and manage records through applicable lifecycle phases. 

• Track pre-implementation, implementation, and post-implementation tasks, dependencies, due dates, and deliverables; follow up with task owners and escalate risks or delays.Verify that task completion documentation includes the required objective evidence, traceability, and supporting information before routing for approval or closure. 

• Maintain trackers and provide clear, routinestatusreadinessupdates to NPI management and cross-functional partners. 

• Build effective relationships across functions, communicate moderately complex issues clearly, navigate ambiguity, and apply structured problem-solving to supporttimely execution. 

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Win 

What we expectof you 

We are all different, yet we all use our unique contributions to serve patients. The detail-oriented manufacturing professional weseek has experience in GMP manufacturing or manufacturing support, with strong cross-functional coordination, meeting facilitation, technical writing, and quality-system skills as well as the below qualifications. 

Basic Qualifications: 

• Master’s degree OR 

• Bachelor’s degree and 4 years of Manufacturing or Operations experience OR 

• Associate’s degree and 8 years of Manufacturing or Operations experience OR 

• High school diploma / GED and 10 years of Manufacturing or Operations experience 

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Preferred Qualifications: 

• Degree in Science, Engineering, Supply Chain, Operations, ora related field. 

• Experience in GMP biotechnology or pharmaceutical manufacturing, manufacturing support, Process Development, Quality, or Supply Chain. 

• Experiencefacilitating cross-functional Quality Risk Assessments, FMEAs, or similar structuredrisk-management activities. 

• Experience using Quality Management Systems such as Veeva QMS orTrackWise for Change Controls, Continuous Improvement records, deviations, CAPAs, or risk-related records. 

• Experience creating ormaintaining process or manufacturing Bills of Materials and coordinating material readiness across multiple functions. 

• Working knowledge of drug substance manufacturing and the relationship between process requirements, materials, manufacturing documents, and electronic batch records or MES. 

• Strong cross-functional project coordination, meeting facilitation, technical writing, and compliant documentation skills. 

• Ability to manage multiple priorities,maintain trackers, follow up on actions, and deliver work toestablished timelines. 

• Excellent written and verbal communication skills with the ability to build effective relationships in a matrix environment. 

• Ability to work independently within a defined scope, recognize when guidance is needed, and escalate risks promptly. 

Thrive 

What you can expectof 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 salary range for this opportunity in the U.S. is [HR to input market pay range]. 

In addition to the base salary, Amgen offers a Total Rewards Plancomprising 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. 

Apply now 

for a career that defies imagination 

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

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