Holly Springs, North Carolina, United States · On-site
$154k–$209k/yr
Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? 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…
Skills: People Leadership, Deviation Management, Root Cause Analysis, CAPA Management, Investigation Leadership
Thousand Oaks, California, United States · Hybrid
$151k–$204k/yr
Career CategorySales & Marketing OperationsJob DescriptionJoin 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 li…
Skills: Agentic AI, Generative AI, Commercial Analytics, AI/ML Delivery, Project Management
Hyderabad, Telangana, India · On-site
Career CategoryMarketingJob Description About the Role: As a UX Designer supporting the Amgen Design System, you will contribute to the creation, evolution, and adoption of scalable UI components and patterns across mult…
Skills: Figma, Design Systems, Adobe Experience Manager, UI Components, Web Accessibility
West Greenwich, Rhode Island, United States · On-site
$132k–$179k/yr
Career CategoryOperationsJob 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…
Skills: Regulatory Compliance, Inspection Readiness, cGMP, Quality Assurance, Audit Management
Hyderabad, Telangana, India · On-site
Career CategoryMarketingJob Description About the Role: As a UX Designer supporting the Amgen Design System, you will contribute to the creation, evolution, and adoption of scalable UI components and patterns across mult…
Skills: Design Operations, Design Systems, Adobe Experience Manager, Figma, Stakeholder Management
Cambridge, England, United Kingdom · Hybrid
Career CategoryHuman ResourcesJob Description Amgen is one of the world’s leading independent biotechnology companies. For over four decades, Amgen has pioneered biotechnology breakthroughs to bring state of the art medi…
Skills: HR Investigations, Employee Relations, Employment Law, Performance Management, Conflict Resolution
Dublin, Leinster, Ireland · Hybrid
$67k–$91k/yr
Career CategoryHuman ResourcesJob Description Amgen is one of the world’s leading independent biotechnology companies. For over four decades, Amgen has pioneered biotechnology breakthroughs to bring state of the art medi…
Skills: HR Investigations, Employee Relations, Employment Law, Performance Management, Conflict Resolution
Thousand Oaks, California, United States · Remote OK
$82k–$110k/yr
Career CategoryGovernment AffairsJob 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…
Skills: Financial Modeling, Forecasting, Scenario Planning, Healthcare Policy Analysis, Quantitative Assessment
Hyderabad, Telangana, India · On-site
Career CategorySales & Marketing OperationsJob Description Level: Senior Manager (L6) Role: Marketing Investment Optimization - Digital Analytics MIO OVERVIEW The Marketing Investment Optimization (MIO) vertical at Amgen…
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Thousand Oaks, California, United States · On-site
$108k–$146k/yr
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Hyderabad, Telangana, India · Hybrid
Career CategoryInformation SystemsJob Description We are seeking a skilled Reltio MDM Developer with 5-8 years of experience in Master Data Management (MDM) to design, develop, and implement scalable MDM solutions on the…
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Holly Springs, North Carolina, United States · On-site
$108k–$146k/yr
Career CategoryManufacturingJob 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…
Skills: Project Management, Biologics Manufacturing, Technical Writing, Lean Manufacturing, Root Cause Analysis
Holly Springs, North Carolina, United States · On-site
$108k–$146k/yr
Career CategoryManufacturingJob 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…
Skills: Project Management, Biologics Manufacturing, Downstream Processing, Technical Writing, Lean Manufacturing
Holly Springs, North Carolina, United States · On-site
$108k–$146k/yr
Career CategoryManufacturingJob 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…
Skills: Project Management, Biologics Manufacturing, Technical Writing, Lean Manufacturing, Cross-functional Communication
Hyderabad, Telangana, India · On-site
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Skills: React, Angular, Fast API, Python, Java
Hyderabad, Telangana, India · On-site
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Skills: Python, R, SQL, Databricks, Snowflake
Holly Springs, North Carolina, United States · On-site
$137k–$185k/yr
Career CategoryEngineeringJob DescriptionJoin 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…
Skills: Emerson DeltaV, Process Control Network Design, Virtual Infrastructure, System Integration, OPC
Hyderabad, Telangana, India · On-site
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Skills: Large Language Models, Agentic AI, Python, RAG, Vector Databases
Thousand Oaks, California, United States · Hybrid
$137k–$186k/yr
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Skills: Secondary Data Analysis, KPI Establishment, Performance Management, Market Research, Competitive Intelligence
Hyderabad, Telangana, India · On-site
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Skills: Clinical Study Management, Vendor Management, Risk Monitoring, CTMS, eTMF
Holly Springs, North Carolina, United States • On-site
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Lead the Major Deviation Investigation Team to oversee quality and compliance investigations across various ANC operations. Establish investigation standards and governance while championing Human and Organizational Performance (HOP) principles to ensure sustainable problem resolution.
Requires a degree (ranging from High School to Doctorate) with corresponding biotechnology or pharmaceutical industry experience and at least 2 years of people management experience. Preferred candidates have 8+ years of industry experience and a strong background in deviation management and CAPA.
HOW MIGHT YOU DEFY IMAGINATION?
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.
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 single use 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.
Senior Manager – Manufacturing Programs
Live
What you will do
We are seeking a Senior Manager of Manufacturing Programs to lead the Process Owner organization within Manufacturing Support at ANC. This leadership role is responsible for providing technical process stewardship, manufacturing support, process governance, and manufacturing change control support for Upstream, Downstream, and Services Drug Substance Unit Operations.
The Process Owner team serves as the technical process steward for manufacturing operations, partnering closely with Manufacturing Operations and cross-functional support functions to ensure manufacturing processes are effectively governed, implemented, maintained, and continuously improved throughout their lifecycle.
Process Owners serve as the primary technical liaisons between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, Commissioning & Qualification (C&Q), Supply Chain, and Digital Manufacturing. Through floor presence, hypercare support, process ownership, operational readiness activities, and manufacturing change implementation, the team enables reliable, compliant, and efficient manufacturing execution.
The Senior Manager will lead a growing organization of Process Owners responsible for process ownership, floor support and hypercare activities, operational readiness assessments, dry and water run execution, electronic batch record implementation support, manufacturing change implementation, BOM support, and procedural governance. This role will also be responsible for expanding organizational capabilities, including establishing and leading a swing-shift Process Owner team to provide enhanced operational support and manufacturing coverage.
What You Will Do
Lead and develop the Process Owner organization responsible for providing technical process stewardship and manufacturing support for Upstream, Downstream, and Services Drug Substance Unit Operations.
Provide direct management, coaching, mentoring, and career development for Process Owners.
Develop and implement a swing-shift Process Owner organization to provide expanded manufacturing support and floor coverage.
Foster a culture of safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.
Provide strategic leadership for process ownership, operational readiness, manufacturing change implementation, manufacturing procedures, manufacturing CAPAs, and technical process stewardship.
Coordinate with site scheduling to ensure Process Owners provide timely hyper-care support and technical assistance during manufacturing campaigns, startup activities, process changes, first-time executions, and routine operations.
Serve as the primary interface between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.
Oversee execution of dry runs, water runs, engineering runs, and operational readiness activities supporting manufacturing.
Own manufacturing-related CAPAs and change controls associated with process, procedural, and operational improvements.
Provide leadership and input for electronic batch record (EBR) and manufacturing execution system (MES) implementation activities impacting manufacturing operations.
Partner with Technology teams to ensure manufacturing processes are effectively translated into digital workflows and manufacturing execution platforms.
Partner with Supply Chain organizations to ensure manufacturing processes, material strategies, and Bill of Materials (BOM) support efficient manufacturing execution.
Provide process ownership oversight for BOM creation, maintenance, and updates associated with manufacturing process changes.
Ensure creation, revision, maintenance, and periodic review of GMP documentation supporting manufacturing operations.
Drive strategic initiatives to improve process reliability, manufacturing efficiency, operator experience, and operational performance.
Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections as required.
What We Expect of You
Basic Qualifications:
Doctorate degree and 2 years of biotechnology or pharmaceutical industry experience
OR
Master’s degree and 6 years of biotechnology or pharmaceutical industry experience
OR
Bachelor’s degree and 8 years of biotechnology or pharmaceutical industry experience
OR
Associate’s degree and 10 years of biotechnology or pharmaceutical industry experience
OR
High school diploma / GED and 12 years of biotechnology or pharmaceutical industry experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
8+ years related work experience in biotechnology or pharmaceutical manufacturing with progressively increasing responsibility.
Prior people leadership experience managing and developing technical teams.
Strong understanding of GMP manufacturing operations supporting Upstream, Downstream, and Services Drug Substance Unit Operations.
Experience with process ownership, manufacturing support, and technical process stewardship.
Experience supporting digital manufacturing systems, electronic batch records (EBRs), manufacturing execution systems (MES), and associated process implementation activities within a GMP manufacturing environment.
Experience authoring, approving, and governing manufacturing SOPs and GMP documentation within Quality Systems (i.e. Veeva, Documentum, etc.).
Experience leading manufacturing CAPAs/change controls and implementation activities.
Experience supporting operational readiness activities, including dry runs, water runs, process implementation, and startup support.
Experience partnering with Supply Chain organizations to support BOM management, material readiness, and manufacturing execution.
Excellent organizational, written, verbal communication, and cross-functional leadership skills.
#WeareBiotech
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
#WeareBiotech
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
