Manager Manufacturing Programs – Process Owner Team
Amgen
Manager Manufacturing Programs – Process Owner Team
Job Description
Career CategoryManufacturingJob DescriptionHOW 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. Be part of Amgen North Carolina's newest and most advanced drug substance manufacturing facility, combining single-use technologies, traditional processing equipment, Industry 4.0 capabilities, and sustainability innovations. Manager Manufacturing Programs – Process Owner Team Live What You Will Do In this vital role, you will lead a team of Process Owners within the Manufacturing Support organization at Amgen North Carolina (ANC). This position may lead either an Upstream & Services-focused team or a Downstream-focused team and requires strong technical expertise in the applicable manufacturing area combined with demonstrated people leadership capabilities. The Process Owner Team serves as a critical technical interface between Manufacturing Operations and support organizations, ensuring manufacturing processes are effectively translated into operational execution, manufacturing procedures, and digital manufacturing workflows. The team provides technical process stewardship, manufacturing floor support, operational readiness, CAPA implementation support, manufacturing change management, and procedural governance to enable safe, compliant, and reliable manufacturing operations. Lead, coach, develop, and manage a team of Process Owners supporting GMP drug substance manufacturing operations. Foster a culture of safety, quality, compliance, accountability, collaboration, and continuous improvement. Provide leadership for technical process stewardship, manufacturing support, operational readiness, and process governance activities. Ensure Process Owners provide effective floor support, hypercare, troubleshooting assistance, and manufacturing execution support. Oversee operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing support. Drive accountability for execution and timely closure of Process Owner commitments associated with CAPAs, risk assessments, investigation support activities, change controls, and operational readiness activities. Lead manufacturing-related change control implementation activities impacting manufacturing operations (excluding NPI-related change controls). Ensure manufacturing processes are effectively translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes. Partner with Manufacturing, Process Development, Quality, Engineering, Supply Chain, Facilities & Engineering, and Digital Manufacturing to support facility fit assessments, process overviews, process implementation, and continuous improvement initiatives. Support BOM readiness activities and alignment of single-use assemblies, consumables, and process materials with manufacturing requirements. Ensure appropriate escalation and communication of manufacturing, quality, compliance, and operational risks. Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections. Win What We Expect of You Basic Qualifications Doctorate degree OR Master's degree and 3 years of biotechnology or pharmaceutical manufacturing experience OR Bachelor's degree and 5 years of biotechnology or pharmaceutical manufacturing experience OR Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing experience In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications 7+ years of biotechnology or pharmaceutical manufacturing experience with progressively increasing responsibility. Demonstrated people leadership experience managing, coaching, and developing technical teams. Strong technical expertise in either Upstream & Services manufacturing operations or Downstream manufacturing operations. Experience with GMP manufacturing operations, process stewardship, and manufacturing support. Experience supporting operational readiness activities, including water runs, dry runs, equipment testing, and startup support. Experience with CAPA implementation, CAPA applicability assessments, effectiveness checks, risk assessments, and root cause analysis support. Knowledge of drug substance manufacturing equipment, process flows, and manufacturing operations. Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment. Knowledge of single-use technologies and Bill of Material (BOM) structures. Experience partnering with Process Development on facility fit assessments, process implementation, and knowledge transfer activities. Strong communication, organizational, and cross-functional leadership skills. Thrive 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 through comprehensive benefits, career development opportunities, and a collaborative culture. .Salary RangeUSD - USD
Locations
- US - North Carolina - Holly Springs
Skills Required
- progressively increasing responsibilityintermediate
- either Upstream & Services manufacturing operationsintermediate
- GMP manufacturing operationsintermediate
- CAPA implementationintermediate
- drug substance manufacturing equipmentintermediate
- single-use technologiesintermediate
Required Qualifications
- Doctorate degree OR (degree)
- Doctorate degree OR (degree)
- Master's degree and 3 years of biotechnology or pharmaceutical manufacturing experience OR (experience, 3 years)
- Master's degree and 3 years of biotechnology or pharmaceutical manufacturing experience OR (experience, 3 years)
- Bachelor's degree and 5 years of biotechnology or pharmaceutical manufacturing experience OR (experience, 5 years)
- Bachelor's degree and 5 years of biotechnology or pharmaceutical manufacturing experience OR (experience, 5 years)
- Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR (experience, 10 years)
- Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR (experience, 10 years)
- High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing experience (experience, 12 years)
- High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing experience (experience, 12 years)
- In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above (experience)
- In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above (experience)
Preferred Qualifications
- 7+ years of biotechnology or pharmaceutical manufacturing experience with progressively increasing responsibility. (experience, 7 years)
- 7+ years of biotechnology or pharmaceutical manufacturing experience with progressively increasing responsibility. (experience, 7 years)
- Demonstrated people leadership experience managing, coaching, and developing technical teams. (experience)
- Demonstrated people leadership experience managing, coaching, and developing technical teams. (experience)
- Strong technical expertise in either Upstream & Services manufacturing operations or Downstream manufacturing operations. (experience)
- Strong technical expertise in either Upstream & Services manufacturing operations or Downstream manufacturing operations. (experience)
- Experience with GMP manufacturing operations, process stewardship, and manufacturing support. (experience)
- Experience with GMP manufacturing operations, process stewardship, and manufacturing support. (experience)
- Experience supporting operational readiness activities, including water runs, dry runs, equipment testing, and startup support. (experience)
- Experience supporting operational readiness activities, including water runs, dry runs, equipment testing, and startup support. (experience)
- Experience with CAPA implementation, CAPA applicability assessments, effectiveness checks, risk assessments, and root cause analysis support. (experience)
- Experience with CAPA implementation, CAPA applicability assessments, effectiveness checks, risk assessments, and root cause analysis support. (experience)
- Knowledge of drug substance manufacturing equipment, process flows, and manufacturing operations. (experience)
- Knowledge of drug substance manufacturing equipment, process flows, and manufacturing operations. (experience)
- Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment. (experience)
- Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment. (experience)
- Knowledge of single-use technologies and Bill of Material (BOM) structures. (experience)
- Knowledge of single-use technologies and Bill of Material (BOM) structures. (experience)
- Experience partnering with Process Development on facility fit assessments, process implementation, and knowledge transfer activities. (experience)
- Experience partnering with Process Development on facility fit assessments, process implementation, and knowledge transfer activities. (experience)
- Strong communication, organizational, and cross-functional leadership skills. (experience)
- Strong communication, organizational, and cross-functional leadership skills. (experience)
Responsibilities
- In this vital role, you will lead a team of Process Owners within the Manufacturing Support organization at Amgen North Carolina (ANC). This position may lead either an Upstream & Services-focused team or a Downstream-focused team and requires strong technical expertise in the applicable manufacturing area combined with demonstrated people leadership capabilities.
- The Process Owner Team serves as a critical technical interface between Manufacturing Operations and support organizations, ensuring manufacturing processes are effectively translated into operational execution, manufacturing procedures, and digital manufacturing workflows. The team provides technical process stewardship, manufacturing floor support, operational readiness, CAPA implementation support, manufacturing change management, and procedural governance to enable safe, compliant, and reliable manufacturing operations.
- Lead, coach, develop, and manage a team of Process Owners supporting GMP drug substance manufacturing operations.
- Lead, coach, develop, and manage a team of Process Owners supporting GMP drug substance manufacturing operations.
- Foster a culture of safety, quality, compliance, accountability, collaboration, and continuous improvement.
- Foster a culture of safety, quality, compliance, accountability, collaboration, and continuous improvement.
- Provide leadership for technical process stewardship, manufacturing support, operational readiness, and process governance activities.
- Provide leadership for technical process stewardship, manufacturing support, operational readiness, and process governance activities.
- Ensure Process Owners provide effective floor support, hypercare, troubleshooting assistance, and manufacturing execution support.
- Ensure Process Owners provide effective floor support, hypercare, troubleshooting assistance, and manufacturing execution support.
- Oversee operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing support.
- Oversee operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing support.
- Drive accountability for execution and timely closure of Process Owner commitments associated with CAPAs, risk assessments, investigation support activities, change controls, and operational readiness activities.
- Drive accountability for execution and timely closure of Process Owner commitments associated with CAPAs, risk assessments, investigation support activities, change controls, and operational readiness activities.
- Lead manufacturing-related change control implementation activities impacting manufacturing operations (excluding NPI-related change controls).
- Lead manufacturing-related change control implementation activities impacting manufacturing operations (excluding NPI-related change controls).
- Ensure manufacturing processes are effectively translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.
- Ensure manufacturing processes are effectively translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.
- Partner with Manufacturing, Process Development, Quality, Engineering, Supply Chain, Facilities & Engineering, and Digital Manufacturing to support facility fit assessments, process overviews, process implementation, and continuous improvement initiatives.
- Partner with Manufacturing, Process Development, Quality, Engineering, Supply Chain, Facilities & Engineering, and Digital Manufacturing to support facility fit assessments, process overviews, process implementation, and continuous improvement initiatives.
- Support BOM readiness activities and alignment of single-use assemblies, consumables, and process materials with manufacturing requirements.
- Support BOM readiness activities and alignment of single-use assemblies, consumables, and process materials with manufacturing requirements.
- Ensure appropriate escalation and communication of manufacturing, quality, compliance, and operational risks.
- Ensure appropriate escalation and communication of manufacturing, quality, compliance, and operational risks.
- Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections.
- Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections.
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