Manufacturing Associate, Bulk Drug Substance Upstream - Days

Live

What you will do

Let’sdo this! Let’schange the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The schedule isa rotating 2-2-3, 5:45AM-6:15PM(12-hour shift). Associates will be completing operations on the floor in our upstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.

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

Responsibilities will include...

Compliance:

• Completes workin accordance withestablished 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

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Process/Equipment/Facilities:

• Perform hands-on operations including set-up, cleaning, sanitization,monitoringof equipment and assigned area

• Run andmonitorcritical process tasks per assigned procedures

• Perform in-process sampling,operateanalytical equipment, and complete process documentation (Electronic Batch Records [EBRs])

• Identifyand escalate issues and concerns regardingdaily 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

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Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals weseekare 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

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Preferred Qualifications:

• Completion of NCBioWorksCertification 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 todemonstratedesire and drive to learn and grow their understanding of operations and processes

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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 Plancomprisinghealth 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

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Apply now

for a career that defies imagination

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

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