Associate Manufacturing - Bulk Drug Substance Downstream - Days

Career Category

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 over10 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 AmgenFleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleX 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

Live 

What youwill 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 willbe part of a team responsible for manufacturing downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and finalfill , while partnering across functions to ensure successful operational readiness, technology transfer, andramp‑up of manufacturing operations within the new facility.  

This role may require work outside standard business hours, includingnon‑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 steadystate operations, the role will shift toward routine manufacturing execution and continuous improvement. 

With general direction, the Associate will support all floor operationsin accordance withcGMP practices. 

Key Responsibilities: 

Compliance & Quality 

• Execute workin 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 operations 

• Follow defined workflows and procedures to support safe and compliant startup activities 

• Provide operational feedback and escalate issuesobserved during startup execution 

Manufacturing Operations 

• Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and assigned areas 

• Run andmonitor critical process tasksper approved procedures 

• Perform inprocess sampling,operate analytical equipment, and complete Electronic Batch Records (EBRs) 

• Complete washroom activities for small‑ tolarge‑scale manufacturing equipment 

• Identify and escalate operational issuesimpacting safety, quality, or schedule 

• Maintain an organized, clean, and compliant manufacturing environment 

Win 

What we expectof you 

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

Basic Qualifications: 

• High School/GED + 2 years manufacturingand/or other regulated environmentexperience  

Or 

• Associate’s Degree + 6 monthsmanufacturing and/or other regulated environment experience  

Or 

• Bachelor’s Degree 

Preferred Qualifications: 

• Completion of NCBioWorks Certification Program 

• Experience inaregulated industry such asbiotechnology or pharmaceutical  

• Basic understanding andprocessexperience in a cGMPmanufacturing facility 

• Strong verbal and written communication  

• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V,andElectronicQualitySystems 

• An ability todemonstrate 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 expectof us 

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.  

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 Plancomprising 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 

Apply now 

for a career that defies imagination 

Objects in your future are closer than they appear. Join us. 

careers.amgen.com 

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 areprovided reasonable accommodation toparticipate 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. 

Salary Range