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Join Amgen’s Mission of Serving Patients. In this vital role you will perform operations in Manufacturing (AR30), specifically in downstream operations, at Amgen's innovative Rhode Island facility.
Job Responsibility:
Perform operations in Manufacturing (AR30), specifically in downstream operations
Perform and monitor critical processes associated with protein purification while following Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs) and batch records
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 work space
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
Work a 12-hour shift on a rotating schedule (7AM-7PM, with a two-week rotation covering 7 days per rotation)
Requirements:
High school/GED + 2 years of manufacturing or operations work experience
Associate’s + 6 months of manufacturing or operations work experience
Bachelor’s Degree in a related field
Nice to have:
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
What we offer:
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, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible