Associate Manufacturing - Bulk Drug Substance Downstream - Days

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 71,000 - 96,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible work model

Job summary

Amgen North Carolina seeks an Associate Manufacturing - Bulk Drug Substance Downstream to support the facility expansion and startup. You’ll work on downstream purification operations, including chromatography, filtration and tangential flow filtration, ensuring readiness and transfer to routine manufacturing.

In this 12‑hour shift environment, you’ll contribute to commissioning, qualification and early manufacturing activities, with emphasis on safety, quality and regulatory compliance, while

Qualifications

• Bachelor’s Degree or equivalent in a science/engineering field
• Associate’s Degree plus 6 months manufacturing/regulatory experience or High School/GED plus 2 years in regulated environment
• Experience in a cGMP manufacturing facility or biotechnology/pharma environment preferred

Responsibilities

• Perform hands‑on downstream manufacturing operations including setup, monitoring, cleaning and sanitization of equipment and areas
• Execute critical process tasks and monitor processes per approved procedures
• Complete Electronic Batch Records (EBRs) and perform in‑process sampling and analyses
• Identify and escalate safety, quality or schedule issues in a timely manner
• Support readiness, commissioning, qualification and early manufacturing activities

Skills

cGMP awareness

Quality documentation

Team collaboration

Education

Bachelor’s Degree

Associate’s Degree

High School/GED

Tools

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Career Category Manufacturing 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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 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 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 – 5pm. 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. 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‑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 escalated issues observed during startup execution
• Manufacturing Operations Perform hands‑on manufacturing operations including setup, operation, monitoring, cleaning, 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 escalat 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.

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
• Thrive

What you can expect of us

• 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

Salary Range 70,985.20USD -96,038.80 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen