Specialist Manufacturing – Process Owner Upstream Downstream Services

Live

What You Will Do

In this vital role you will serve as a Process Owner within the Manufacturing Support organization atAmgenNorth Carolina (ANC). The Process Owner serves as a technical process steward and key interface between Manufacturing Operations and support organizations. This roleis responsible forsupporting manufacturing execution through technical process ownership floor support operational readiness activities process governance manufacturing change implementation support and continuous improvement initiatives.

This position may support one of the following manufacturing areas depending on business needs and organizational assignment: Upstream Manufacturing Downstream Manufacturing or Manufacturing Services (Raw Material Dispensing and Solution Preparation).

• Serve as the technical process owner for assigned manufacturing processes equipment and unit operations.

• Provide manufacturing floor support troubleshootingassistance andhypercareduring routine manufacturing operations process changes startup activities and first-time executions.

• Support operational readiness activities including water runs dry runs equipment readiness verification and Electronic Batch Record (EBR) testingsupport.

• Partner with Manufacturing Operations to support reliable compliant and efficient manufacturing execution.

• Monitor process performance andidentifyopportunities for process optimization operational improvement and risk reduction.

• Support manufacturing-related change controls associated with process equipment procedural and operational improvements.

• Author revise review andmaintainmanufacturing SOPs forms and other GMP documentation.

• Ensure manufacturing processes are effectively translated into SOPs manufacturing workflows training materials and associated digital manufacturing processes.

• Provide technical input to manufacturing risk assessments and support identification and mitigation of process equipment procedural and operational risks.

• Participate in root cause analysis (RCA) activities and provide technical processexpertiseto support manufacturing investigations major deviations and quality events.

• Support CAPA applicability assessments CAPA implementation activities and CAPA effectiveness checks.

• Partner with Process Development to support process overviews knowledge transfer activities and facility fit assessments.

• Partner with Supply Chain Manufacturing and Engineering to support material readiness and Bill of Material (BOM) alignment including single-use assemblies and consumables.

• Support MES and EBR activities by providing processexpertiseand manufacturing representation.

• Participate ininspectionreadiness activities and support audits as.

• Appropriately escalate process operational quality and compliance concerns.

Win

What We Expect of You

Basic Qualifications

• Doctorate degree and 2 years of biotechnology operations experience OR

• Masters degree in Engineering Biology Chemistry Biochemistry or related field and 4 years of biotechnology operations experience OR

• Bachelors degree and 6 years of biotechnology operations experience OR

• Associates degree and 10 years of biotechnology operations experience OR

• High school diploma / GED and 12 years of biotechnology operations experience

Preferred Qualifications

• Technicalexpertisein Upstream Manufacturing Downstream Manufacturing or Manufacturing Services (Raw Material Dispensing and Solution Preparation).

• Strong technical knowledge of drug substance manufacturing processes equipment and unit operations.

• Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment.

• Experience supporting manufacturing floor operations troubleshooting andhypercareactivities.

• Experience supporting operational readiness activities including water runs dry runs equipment testing and startup support.

• Experience authoring and maintaining GMP documentation including SOPs and manufacturing procedures.

• Experience supporting manufacturing change controls and implementation activities.

• Experienceparticipatingin risk assessments root cause analyses investigations and CAPA implementation activities.

• Experience supporting CAPA applicability assessments and effectiveness checks.

• 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.

• Strong technical writing communication problem-solving and organizational 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.