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Senior Associate Manufacturing Services - Night Shift

Amgen
Amgen
2-6 years
$88,378 – $106,188 USD
10 Nov. 4, 2025
Job Description
Job Type: Full Time 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

Position Title:

Senior Associate Manufacturing Services – Night Shift

Location:

US – North Carolina – Holly Springs

Job ID:

R-229002

Work Location Type:

On Site

Date Posted:

October 30, 2025

Category:

Manufacturing

Salary Range:

$88,378 – $106,188 USD (Annual)


About Amgen

At Amgen, you’re part of something bigger — a shared mission to serve patients living with serious illnesses.
Since 1980, Amgen has led the biotechnology industry in developing innovative therapies targeting the world’s toughest diseases.

With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, Amgen’s science-based and collaborative culture helps millions of patients live longer and healthier lives.


About the Holly Springs Facility

Join Amgen’s newest and most advanced manufacturing site, the FleX Batch Facility, located in Holly Springs, North Carolina.

This state-of-the-art plant combines:

  • Disposable technologies with stainless-steel systems for flexible operations

  • Industry 4.0 digital manufacturing capabilities

  • Sustainability innovations supporting Amgen’s goal to be carbon-neutral by 2027


Position Summary

The Senior Associate, Manufacturing Services (Night Shift) will play a vital role in executing floor operations within Amgen North Carolina’s manufacturing organization.

This position involves producing cGMP-compliant drug substances and ensuring smooth, safe, and efficient manufacturing performance.

  • Shift Schedule: Rotating 2-2-3, 12-hour shift (5:45 PM – 6:15 AM)

  • Work Environment: On-site manufacturing operations


Key Responsibilities

1. Compliance

  • Execute manufacturing operations per cGMP, SOPs, Manufacturing Procedures (MPs), JHAs, and CFR standards.

  • Maintain strict adherence to safety and regulatory compliance.

  • Prepare and manage deviation reports as necessary.

  • Follow and uphold aseptic gowning and cleanroom practices.

  • Interact with regulatory agencies as directed.


2. Process / Equipment / Facilities

  • Perform hands-on operational tasks, including equipment setup, cleaning, sanitization, and area monitoring.

  • Execute critical process operations per manufacturing instructions.

  • Conduct in-process sampling and operate analytical instruments.

  • Complete Electronic Batch Records (EBR) and other process documentation.

  • Perform equipment washroom activities (small to large-scale cleaning).

  • Identify and propose process optimizations and efficiency improvements.

  • Review equipment logs and documentation for accuracy.

  • Collaborate with cross-functional teams—QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, and Regulatory Affairs.

  • Recognize and escalate operational issues promptly.

  • Support implementation of CAPAs (Corrective and Preventive Actions) and continuous improvement initiatives.

  • Maintain safety standards, report risks, and keep a clean, organized workspace.


3. Administrative / Documentation

  • Draft and revise SOPs, technical reports, and Manufacturing Procedures.

  • Communicate effectively with management regarding schedule concerns and process updates.

  • Support planning and reporting of production activities.


Qualifications

Basic Qualifications

  • High School Diploma / GED + 4 years of experience in manufacturing or other regulated environments, OR

  • Associate’s Degree + 2 years of experience in manufacturing or regulated environments, OR

  • Bachelor’s Degree + 6 months of experience in manufacturing or regulated environments, 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 understanding of cGMP manufacturing and solution/equipment preparation.

  • Experience with inventory control operations.

  • Proficiency in Microsoft Office and familiarity with:

    • MES / EBR systems

    • DeltaV process control systems

    • Electronic Quality Systems

  • Excellent written and verbal communication skills (technical and operational).


What You Can Expect from Amgen

At Amgen, you’ll be supported in your professional and personal growth through:

  • Competitive salary and Total Rewards package aligned with industry standards.

  • Comprehensive benefits, including:

    • Retirement and Savings Plan

    • Medical, Dental, and Vision Insurance

    • Life and Disability Coverage

    • Flexible Spending Accounts

    • Paid time off and holiday programs

  • Access to career development, training, and advancement opportunities.

  • A collaborative and inclusive culture committed to integrity and innovation.


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.

We ensure that individuals with disabilities receive reasonable accommodations during:

  • The application and interview process

  • Job performance and essential functions

  • Access to employment benefits and privileges


Application Details

  • Apply By: Open until sufficient candidates are identified or the position is filled.

  • Apply At: careers.amgen.com