Job Title: Senior Associate Manufacturing Services – Night Shift
Location: Holly Springs, North Carolina, USA
Work Type: On-site
Job ID: R-229001
Date Posted: October 30, 2025
Category: Manufacturing
Salary Range: USD 88,378 – 106,188 per year
About Amgen
At Amgen, you’re part of something bigger — a mission-driven team dedicated to serving patients living with serious illnesses. Since 1980, Amgen has been a leader in biotechnology, developing treatments in four key therapeutic areas:
Oncology
Inflammation
General Medicine
Rare Diseases
Our culture is collaborative, innovative, and science-based, offering professionals the chance to make a lasting global impact while advancing their careers.
About the Facility
Be part of Amgen’s newest and most advanced drug substance manufacturing site — the FleX Batch facility in Holly Springs.
This next-generation plant integrates:
Disposable and stainless-steel technologies for operational flexibility
Industry 4.0 capabilities for digital and data-driven manufacturing
Sustainability innovations to support Amgen’s carbon-neutral by 2027 initiative
Position Overview
As a Senior Associate in Manufacturing Services, you’ll execute on-the-floor operations to support current Good Manufacturing Practice (cGMP) drug substance production at Amgen North Carolina (ANC).
Shift Schedule: Rotating 2-2-3 pattern (12-hour shifts, 5:45 AM – 6:15 PM)
Environment: Hands-on biomanufacturing operations in compliance with strict safety and quality standards
Key Responsibilities
1. Compliance
Perform all work according to cGMP, SOPs, Manufacturing Procedures (MPs), Job Hazard Analyses (JHAs), and CFR guidelines.
Ensure strict adherence to safety, aseptic, and gowning procedures.
Initiate and document deviation reports as needed.
Interact with regulatory agencies under supervision.
2. Process, Equipment, and Facilities
Execute hands-on activities including equipment setup, cleaning, sanitization, and monitoring.
Operate and oversee critical manufacturing processes per defined procedures.
Conduct in-process sampling and operate analytical instruments.
Complete all Electronic Batch Records (EBR) and related documentation.
Manage washroom activities, cleaning small to large-scale production equipment.
Identify and implement process improvements for efficiency and quality.
Collaborate cross-functionally with QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, and Regulatory teams.
Support implementation of CAPAs and continuous improvement programs.
Maintain clean, organized, and compliant workspace standards.
3. Administrative
Draft and revise SOPs, technical reports, and manufacturing procedures.
Communicate and escalate potential scheduling or process issues to management.
Contribute to planning and execution of production-related documentation.
Qualifications
Basic Qualifications
High School Diploma/GED + 4 years’ manufacturing/regulatory environment experience OR
Associate’s Degree + 2 years’ experience OR
Bachelor’s Degree + 6 months’ experience OR
Master’s Degree (no experience required)
Preferred Qualifications
NC BioWorks Certification Program completion
Experience in biotechnology or pharmaceutical plant start-up
Strong understanding of cGMP processes and compliance requirements
Knowledge of solution and equipment preparation, inventory control
Excellent technical communication (verbal and written)
Proficiency in Microsoft Office and electronic systems such as:
EBR/MES (Manufacturing Execution Systems)
DeltaV process automation
Electronic Quality Systems (EQS)
What Amgen Offers
Amgen provides a comprehensive Total Rewards Plan that supports career growth, well-being, and work-life balance. Benefits include:
Competitive base salary and annual bonus
Health, dental, and vision coverage
Retirement and Savings Plan with company contributions
Stock-based long-term incentives
Paid time off and wellness programs
Continuous career development and training opportunities
Collaborative culture fostering innovation and inclusion
Additional Information
Equal Opportunity Employer: Amgen considers all qualified applicants regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, veteran, or disability status.
Accessibility: Reasonable accommodations available for applicants with disabilities upon request.
Application Portal: careers.amgen.com
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