Manufacturing Associate - Holly Springs, NC

VetJobs; Holly Springs (NC); On-site; USD 71,000 - 96,000; Full time

Job summary

Amgen in North Carolina is hiring a Manufacturing Associate for bulk drug substance operations during the ANC2 facility startup. Responsibilities include weigh/dispense raw materials, media and buffer prep, equipment operation, and cGMP documentation.

The role supports startup, qualification, and transition to steady-state manufacturing with a 12-hour shift (5:45 a.m.–6:15 p.m.) as operations scale. Strong teamwork and compliance are essential for success.

Qualifications

• High School/GED with 2 years manufacturing or regulated environment experience or higher education alternatives.
• Associate’s Degree with 6 months manufacturing or regulated environment experience or higher.
• Bachelor’s Degree accepted without additional experience requirements.

Responsibilities

• Comply with cGMP procedures and safety policies in daily tasks.
• Set up, clean, and monitor equipment; perform buffer and media prep.
• Weigh and dispense materials; perform in-process sampling and record results.
• Complete documentation (EBRs) and maintain equipment logs.
• Collaborate across QA/QC, facilities, and manufacturing teams for readiness.
• Maintain a clean, organized work area and properly escalate issues.

Skills

Excellent verbal and written comm

Education

High School/GED

Associate’s Degree

Bachelor’s Degree

Tools

EBR/MES

DeltaV

Electronic Quality Systems (EQS)

Job description

Job Description

Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days

Live

What you will do

Let's do this. Let's change the world! In this dynamic role, you will be an Associate in the Manufacturing organization at Amgen North Carolina (ANC), supporting the ANC2 facility expansion and startup program. This essential role will be part of the Services team responsible for enabling manufacturing operations through weigh and dispense of raw materials, material receiving and handling, media, buffer, and solution preparation, and component preparation activities, including parts washing and autoclave operations. You will also partner across functions to support successful operational readiness, technology transfer, facility startup, and the 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 startup, you will be expected to work a Monday through Friday schedule from 8:00 a.m. to 5:00 p.m. As the business transitions from C&Q to manufacturing operations, this essential position will move to a 12-hour, 2-2-3 schedule from 5:45 a.m. to 6:15 p.m., supporting critical 24/7 manufacturing operations.

Because Amgen relies on the regular attendance of all staff members to meet legitimate business needs, individuals in this role must be able to work their assigned 12-hour shift, including during inclement weather, on some holidays, and during requested overtime in support of operations.

During the early phases of the project, this role will focus on operational readiness, training, procedure development, equipment and process familiarization, and startup execution. As the facility transitions to steady-state operations, the role will shift toward routine manufacturing execution, reliable delivery of materials and prepared solutions, equipment operation, cGMP documentation, and continuous improvement.

With general direction, the Associate will support Services floor operations in accordance with current Good Manufacturing Practices (cGMP), applicable procedures, safety requirements, and established production schedules.

Responsibilities will include

Compliance

• Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
• Assure proper gowning and aseptic techniques are always followed

Process/Equipment/Facilities

• Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment in assigned area
• Run and monitor critical process tasks per assigned procedures
• Buffer and Media preparation and transfer
• Weigh and dispense of materials to be used in the preparation of Buffers and Medias
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities
• Identify and elevate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
• Perform documentation for assigned functions (i.e., equipment logs, EBRs)
• Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
• Maintain an organized, clean, and workable space

Minimum Education Required

High School/GED

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.

Basic Qualifications

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

Preferred Qualifications

• Completion of NC BioWork Certificate Program
• Experience in a regulated industry such as biotechnology or pharmaceutical
• Basic understanding and process experience in a cGMP manufacturing facility
• Excellent 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

Salary Range

70,985.20USD -96,038.80 USD

Salary Range

>$100,000

City*

Holly Springs

State*

North Carolina

Affiliate Sponsor

Amgen