Associate Manufacturing - Bulk Drug Substance Downstream - Days

Associate Manufacturing - Bulk Drug Substance Downstream - 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 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 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 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 inprocess 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

Win

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

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

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 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

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 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.

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Salary Range

70,985.20USD -96,038.80 USD