Services

Amgen•Holly Springs, NC

4d•Onsite

About The Position

Amgen is building a new, advanced drug substance manufacturing plant called FleX Batch, which will combine disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. This facility will feature best-in-class drug substance manufacturing technologies with industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, aligning with Amgen's goal of being a carbon-neutral company by 2027. This role is for a Specialist Manufacturing – Process Owner within the Manufacturing Support organization at Amgen North Carolina (ANC). The Process Owner acts as a technical process steward, bridging Manufacturing Operations and support teams. Responsibilities include supporting manufacturing execution through technical ownership, floor support, operational readiness, process governance, change implementation, and continuous improvement. This position may focus on Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).

Requirements

Doctorate degree and 2 years of biotechnology operations experience OR Master's degree in Engineering, Biology, Chemistry, Biochemistry, or related field and 4 years of biotechnology operations experience OR Bachelor's degree and 6 years of biotechnology operations experience OR Associate's degree and 10 years of biotechnology operations experience OR High school diploma / GED and 12 years of biotechnology operations experience

Nice To Haves

Technical expertise in 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, and hypercare activities.
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.
Experience participating in 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.

Responsibilities

Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.
Provide manufacturing floor support, troubleshooting assistance, and hypercare during 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) testing support.
Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.
Monitor process performance and identify opportunities for process optimization, operational improvement, and risk reduction.
Support manufacturing-related change controls associated with process, equipment, procedural, and operational improvements.
Author, revise, review, and maintain manufacturing 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 process expertise to 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 process expertise and manufacturing representation.
Participate in inspection readiness activities and support audits.
Appropriately escalate process, operational, quality, and compliance concerns.