Senior Manager – Manufacturing Programs - Process Owner Organization
Holly Springs, North Carolina, United States · On-site
$154k–$209k/yr
Senior+$29B raised
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
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Morrisville, North Carolina, United States · On-site
Senior+
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Morrisville, North Carolina, United States · On-site
Senior+
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Kings Mountain, North Carolina, United States · On-site
Entry level
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Asheville, North Carolina, United States · On-site
$17/hr–$31/hr
Entry level$5.0B raised
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Charlotte, North Carolina, United States · On-site
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$81k–$111k/yr
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Kings Mountain, North Carolina, United States · On-site
Entry level$183M raised
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Morrisville, North Carolina, United States · On-site
Senior
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$154k–$209k/yr
Full-time
high school, associate degree, bachelor degree, postgraduate degree
Posted 27d ago
~40 hrs/week
Responsibilities
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.
Requirements
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.
Full job description
Career Category
Manufacturing
Job 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 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 ofManufacturing Programsto 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 changecontrolsupport for Upstream, Downstream, and Services Drug Substance Unit Operations. The Process Ownerteamserves 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,hypercaresupport, 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 andhypercareactivities, 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 activitiessupporting manufacturing.
Own manufacturing-relatedCAPAs andchange controls associated with process, procedural, and operational improvements.
Provide leadership andinputfor electronic batch record (EBR) and manufacturing execution system (MES) implementation activities impacting manufacturing operations.
Partner withTechnologyteams 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.
Win
What We ExpectofYou
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 documentationwithinQuality Systems (i.e. Veeva,Documentum, etc.).
Experience leading manufacturingCAPAs/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.
.
Salary Range
154,173.00USD -208,587.00 USD
Related keywords
BiotechnologyPharmaceuticalsMajor DeviationRoot Cause AnalysisCAPAGMPHuman and Organizational PerformanceHOPIndustry 4.0Drug Substance ManufacturingQuality ControlValidationAutomationSingle Use TechnologiesComplianceGovernance
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
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical
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