Manager Manufacturing Programs – Process Owner Team

Amgen•Holly Springs, NC

31d•Onsite

About The Position

Amgen North Carolina is seeking a Manager Manufacturing Programs – Process Owner Team to lead a team of Process Owners within the Manufacturing Support organization. This role is crucial for bridging Manufacturing Operations with support functions, ensuring seamless translation of manufacturing processes into operational execution, procedures, and digital workflows. The team provides technical stewardship, floor support, operational readiness, CAPA implementation support, change management, and procedural governance to ensure safe, compliant, and reliable manufacturing operations. This position may focus on either Upstream & Services or Downstream manufacturing.

Requirements

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
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
Managerial experience may run concurrently with the required technical experience.

Nice To Haves

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.

Responsibilities

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.