Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days

Amgen•Holly Springs, NC

About The Position

The Senior Associate Downstream Manufacturing works in the manufacturing organization at Amgen North Carolina and performs on-the-floor operations in Manufacturing Services areas to manufacture cGMP drug substance. The role operates with general direction and requires strict adherence to safety, compliance, and established procedures. The initial schedule is Monday through Friday, eight-hour days, and may include work from home; it may transition to a 12-hour day or night shift as business needs dictate. The position involves equipment and area setup, cleaning, sanitization, monitoring, process execution, in-process sampling, analytical equipment operation, documentation, and washroom activities. The Senior Associate also supports document review and revision, process improvements, CAPA implementation, cross-functional production work, and escalation of operational or safety concerns. The role is part of work at Amgen’s FleX Batch facility, which is described as incorporating disposable technologies, stainless-steel equipment, Industry 4.0 capabilities, and sustainability innovations.

Requirements

High school diploma or GED and at least 4 years of manufacturing and/or other regulated-environment experience; or an associate degree and at least 2 years of such experience; or a bachelor's degree and at least 6 months of such experience; or a master's degree.
Strong understanding of solution preparation, equipment preparation, and inventory control operations.
Excellent verbal and written technical communication skills.
Proficiency in Microsoft Office.

Nice To Haves

Completion of the NC BioWorks Certification Program.
Experience in biotechnology or pharmaceutical plant start-up.
Knowledge of and process experience in a cGMP manufacturing facility or another highly regulated environment.
Knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.

Responsibilities

Complete work in accordance with cGMP procedures and policies, including SOPs, Manufacturing Procedures, Job Hazard Analyses, and applicable regulations, while adhering strictly to safety and compliance requirements.
Initiate deviation reports.
Interact with regulatory agencies as needed and when guided.
Ensure proper gowning and aseptic techniques are followed.
Set up, clean, sanitize, and monitor equipment and assigned areas.
Run and monitor critical process tasks according to assigned procedures.
Perform in-process sampling, operate analytical equipment, and complete process documentation, including Electronic Batch Records.
Complete washroom activities, including cleaning production equipment of varying scales.
Identify, recommend, and implement process improvements and optimizations related to routine functions.
Assist in reviewing documentation for assigned functions, such as equipment logs and Electronic Batch Records.
Collaborate with cross-functional teams, including QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, and Regulatory, to complete production activities.
Recognize and elevate problems during daily operations.
Participate in implementing programs and CAPAs with a focus on continuous improvement.
Promote safety in all operations and assist the manager in escalating concerns as needed.
Maintain an organized, clean, and workable space.
Draft and revise documents, including SOPs, technical reports, and Manufacturing Procedures.
Advise management in planning and escalate potential schedule or process concerns.