Associate Manufacturing - Bulk Drug Substance Downstream - Days

BioSpace; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Flexible work models

Total Rewards Plan

Stock-based incentives

Job summary

Amgen North Carolina seeks an Associate Manufacturing - Bulk Drug Substance Downstream to join the expanding facility. You will perform downstream purification operations such as column packing, chromatography, TFF, viral filtration, and conjugation, contributing to readiness, tech transfer, and ramp-up.

The role includes a 12-hour shift during startup and a 12-hour 2-2-3 schedule during steady-state, with compliance to cGMP and collaboration across functions.

Qualifications

• Experience in regulated manufacturing environments.
• Familiarity with cGMP practices.
• Ability to work nonstandard hours during startup.

Responsibilities

• 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; complete EBRS and documentation.
• Assist with commissioning, qualification, and early manufacturing operations; support safety, quality, and compliance.

Skills

Communication

Team collaboration

Microsoft Office

cGMP knowledge

Education

High School/GED

Associates/Bachelors degree

NC BioWorks Certification

Tools

EBR/MES systems

DeltaV

Electronic Quality Systems

Job description

HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Associate Manufacturing - Bulk Drug Substance Downstream - Days

What You Will Do

Lets do this! Lets change the world! 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. Thisessentialrole will be part of a team responsible for manufacturingdownstream purification operations including column packing,columnchromatography, TFF,viralfiltration,viralinactivation, conjugation, and final fill,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility. This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm.As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, this role must be able to work assigned 12-hourshift, 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 steadystate operations, the role will shift toward routine manufacturing execution and continuous improvement. With general direction, the Associate will support all floor operations in accordance withcGMP 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 manufacturingrelated 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 ops
• Follow defined workflows and procedures to support safe and compliant startup activities
• Provide operational feedback and elevate 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 largescale manufacturing equipment
• Identify and escalating operational issues impacting safety, quality, or schedule
• Maintain an organized, clean, and compliant manufacturing environment

What We Expect Of You

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

Basic Qualifications

• High School/GED + 2 years manufacturing and/or other regulated environment experience

Or

• Associates Degree + 6 months manufacturing and/or other regulated environment experience

Or

• Bachelors 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

What You Can Expect Of Us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen Offers a Total Rewards Plan Comprising Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities Including

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
• Stock‑based long‑term incentives
• Award‑winning time‑off plans and bi‑annual company‑wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.