Associate Manufacturing - Nights

Role Summary

Associate Manufacturing - Nights at Amgen performing downstream manufacturing operations (AR30) at the Rhode Island facility, focusing on protein purification under GMP, SOP, and batch-record controls. You will monitor critical purification processes and support production within a validated manufacturing environment. The role requires a 12-hour night shift (7:00 PM–7:00 AM) on a rotating schedule, with shift differential and Sunday premium pay, and an onboarding period with standard daytime hours.

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.
• Opportunities to participate in cross-functional teams to expand technical background in the bio-technologies industry.
• Identify, recommend and implement improvements related to CAPAs or Continuous Improvement initiatives.
• Maintaining an inspection ready workspace.
• Organizing and maintaining material inventory in the manufacturing space.
• Collaborating with multiple computer systems (Delta V/EBRs) simultaneously to complete operations or troubleshoot issues on the floor.

Qualifications

• Required: High school/GED + 2 years of manufacturing or operations work experience OR Associate’s + 6 months of manufacturing or operations work experience OR Bachelor’s Degree in a related field
• Preferred: Bachelor’s degree in Science or Engineering
• Preferred: Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
• Preferred: Knowledge of Single-use-Systems
• Preferred: CFR and Regulatory knowledge
• Preferred: Mechanical ability/expertise
• Preferred: Basic statistical mathematical skills
• Preferred: Ability to interpret and apply GMP knowledge
• Preferred: Understanding of analytical methods for manufacturing area
• Preferred: Demonstrated technical writing capability
• Preferred: Able to demonstrate project management skills and presentation skills
• Preferred: Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Preferred: Basic troubleshooting skills on production equipment
• Preferred: Experience with Delta V
• Preferred: Experience with lab equipment/testing