Associate Manufacturing - Bulk Drug Substance Downstream - Days

What you will do

In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup. This essential role will be part of a team responsible for manufacturing downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill, while partnering across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within the new facility.

This role may require work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. During this phase of the startup, you will be expected to work a Monday – Friday schedule from 8am – 5 pm. As the business moves from C&Q to manufacturing operations, this essential position will work on a 12-hour 2-2-3 schedule from 5:45 am to 6:15pm supporting our critical 24/7 manufacturing operations. This role must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our operations.

During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steady state operations, the role will shift toward routine manufacturing execution and continuous improvement. With general direction, the Associate will support all floor operations in accordance with cGMP practices.

Key Responsibilities

Compliance & Quality

• Execute work in accordance with established cGMP procedures and policies, including SOPs, MPs, JHAs, and applicable CFRs
• Ensure proper gowning and aseptic techniques are consistently followed
• Initiate and document manufacturing related deviations and quality events as trained
• Support investigations and corrective actions under guidance
• Maintain a strong culture of safety, quality, and compliance

Operational Readiness & Facility Startup

• Support operational readiness and facility startup activities as part of the expansion program
• Participate in training, equipment familiarization, and procedure execution to enable startup
• Execute assigned readiness tasks supporting commissioning, qualification, and early manufacturing operations
• Follow defined workflows and procedures to support safe and compliant startup activities
• Provide operational feedback and escalate issues observed during startup execution

Manufacturing Operations

• Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and assigned areas
• Run and monitor critical process tasks per approved procedures
• Perform in process sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs)
• Complete washroom activities for small- to large-scale manufacturing equipment
• Identify and escalate operational issues impacting safety, quality, or schedule
• Maintain an organized, clean, and compliant manufacturing environment

Basic Qualifications

• High School/GED + 2 years manufacturing and/or other regulated environment experience
• Or Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
• Or Bachelor’s Degree

Preferred Qualifications

• Completion of NC BioWorks Certification Program
• Experience in a regulated industry such as biotechnology or pharmaceutical
• Basic understanding and process experience in a cGMP manufacturing facility
• Strong verbal and written communication
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
• An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes
• Ability to work effectively in a team-based manufacturing environment