Position Title:
Senior Associate Manufacturing Services (Day Shift)
Location:
US – North Carolina – Holly Springs
Job ID:
R-229000
Work Location Type:
On Site
Date Posted:
November 3, 2025
Category:
Manufacturing
Salary Range:
$88,378 – $106,188 USD (Annual)
About Amgen
At Amgen, we believe in being part of something bigger. Since 1980, we have pioneered biotechnology in the fight against the world’s most serious diseases.
Our focus on Oncology, Inflammation, General Medicine, and Rare Disease has helped millions of patients live longer and healthier lives.
As part of the Amgen team, you’ll work within a collaborative, innovative, and science-driven culture, dedicated to transforming lives and advancing medicine.
About the Holly Springs Site
Be part of Amgen’s newest and most advanced drug substance manufacturing plant—the FleX Batch facility.
This site combines disposable technologies with traditional stainless-steel systems for maximum flexibility, integrates Industry 4.0 innovations, and supports Amgen’s carbon-neutral goal by 2027.
Position Summary
In this role, you will serve as a Senior Associate within the Manufacturing Services team at Amgen North Carolina (ANC).
You will execute on-the-floor manufacturing operations to produce cGMP-compliant drug substances.
Work Schedule: Rotating 2-2-3, 12-hour day shift.
Key Responsibilities
1. Compliance
Perform all tasks in accordance with cGMP, SOPs, Manufacturing Procedures (MPs), and Job Hazard Analyses (JHAs).
Ensure strict adherence to safety and regulatory guidelines.
Initiate and document deviation reports as required.
Maintain proper aseptic techniques and gowning procedures.
Interact with regulatory agencies when necessary.
2. Process / Equipment / Facilities
Execute hands-on operations: setup, cleaning, sanitization, and equipment monitoring.
Operate, monitor, and document critical manufacturing processes.
Conduct in-process sampling and use analytical equipment as per EBR (Electronic Batch Record).
Perform washroom activities for cleaning production equipment (small to large scale).
Identify and implement process improvements and optimizations.
Review production documentation and logs for accuracy.
Collaborate with cross-functional teams (QA, QC, Engineering, PPIC, Process Development, Regulatory, etc.).
Recognize and escalate operational issues promptly.
Participate in CAPA and continuous improvement initiatives.
Maintain a clean, organized, and safe workspace.
3. Administrative / Documentation
Draft, revise, and maintain SOPs, technical reports, and Manufacturing Procedures.
Communicate effectively with management regarding process or scheduling concerns.
Support planning, documentation review, and reporting of production activities.
Qualifications
Basic Qualifications
High School Diploma / GED + 4 years manufacturing or regulated environment experience, OR
Associate’s Degree + 2 years manufacturing or regulated environment experience, OR
Bachelor’s Degree + 6 months manufacturing or regulated environment experience, OR
Master’s Degree (no prior experience required).
Preferred Qualifications
Completion of NC BioWorks Certification Program.
Prior experience in biotechnology or pharmaceutical plant start-up.
Strong knowledge of cGMP operations and solution/equipment preparation.
Experience in inventory control and manufacturing documentation.
Proficiency with Microsoft Office, MES/EBR, DeltaV, and Electronic Quality Systems.
Excellent verbal and technical writing skills.
What Amgen Offers
Competitive base salary and Total Rewards package aligned with industry standards.
Comprehensive benefits, including:
Retirement and Savings Plan
Medical, Dental, and Vision coverage
Life and Disability Insurance
Flexible Spending Accounts
Generous paid time off
Opportunities for career growth, training, and advancement.
A collaborative, ethical, and inclusive workplace culture.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer.
We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
Amgen provides reasonable accommodations for individuals with disabilities during the application, interview, and employment process.
Application Details
Apply By: Open until sufficient candidates are received or position is filled.
Application Portal: careers.amgen.com
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