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Senior Associate Manufacturing Services - Night Shift

4-6 years
88,378.00 USD - 106,188.00 USD
10 Nov. 4, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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