Associate Manufacturing - Days (A Shift)

About the Role

In this vital role, you will perform operations in Manufacturing (AR30), specifically in downstream operations, at Amgen's innovative Rhode Island facility. You will perform and monitor critical processes associated with protein purification while following Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and batch records.

Responsibilities

• Perform in-process sampling of drug substance applying analytical equipment.
• Perform hands-on operations that include inspecting and installing single-use components, chromatography operations, UF/DF operations, sample analysis, drug substance fill operations, and breaking down vessels.
• Perform technical writing to draft and revise documents such as Manufacturing Procedures, Deviations, Safety Reporting, and Equipment logs.
• Conduct basic troubleshooting and assist in the review of documentation for assigned functions.
• Participate in cross-functional teams to expand technical background in the biotechnologies industry.
• Identify, recommend, and implement improvements related to CAPAs or Continuous Improvement initiatives.
• Maintain an inspection-ready workspace.
• Organize and maintain material inventory in the manufacturing space.
• Collaborate with multiple computer systems (Delta V/LIMS/EBRs) simultaneously to complete operations or troubleshoot issues on the floor.

Schedule

This role is expected to work a 12-hour shift on a rotating schedule. The shift pattern will be 7 AM–7 PM, with a two-week rotation covering 7 days per rotation. The rotating shift offers several benefits, with an average of 14 days on shift per month and every other weekend off. Any Sundays worked receive premium pay. The schedule during the initial on-boarding phase for this role (2–6 weeks) will be administrative (Monday through Friday, approximately 8 AM to 5 PM).

Requirements

• High school/GED + 2 years of manufacturing or operations work experience
• OR Associates + 6 months of manufacturing or operations work experience
• OR Bachelor’s Degree in a related field

Preferred Qualifications

• Bachelor’s degree in Science or Engineering
• Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
• Knowledge of Single-use Systems
• CFR and Regulatory knowledge
• Mechanical ability/expertise
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Demonstrated technical writing capability
• Able to demonstrate project management skills and presentation skills
• Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles
• Basic troubleshooting skills on production equipment
• Experience with Delta V
• Experience with lab equipment/testing

Pay

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.

Benefits

• A comprehensive employee benefits package, including:
  • A Retirement and Savings Plan with generous company contributions
  • Group medical, dental, and vision coverage
  • Life and disability insurance
  • 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
• Flexible work models, including remote and hybrid work arrangements, where possible