Associate Manufacturing AME - Days

What you will do

In this vital role you will perform operations within multiple Manufacturing areas, including cell culture and purification, at Amgen's innovative Rhode Island facility. This agile approach helps align staff capability with labor demand peaks across areas while building broader manufacturing experience. You will be required to know, comprehend, and apply Good Manufacturing Practices (GMP), and to understand, follow, and document work in batch records.

Responsibilities Include

• Perform cell culture, purification, weigh & dispense, and solutions batching tasks as part of an Agile Manufacturing Excellence team in two drug substance plants
• Perform tasks in accordance with Standard Operating Procedures (SOPs), Manufacturing Procedures (MPs), Job Hazard Analysis (JHAs), and applicable Code of Federal Regulations (CFRs)
• Perform and monitor critical manufacturing processes
• Conduct basic troubleshooting and assist in the review of documentation for assigned functions; may also have the responsibility of initiating and owning area deviations
• Assist in the review of documentation for assigned functions, including routine area audits and batch records
• Perform activities that may include rigorous and repetitive work
• Work around high-pressure systems and occasionally around heavy equipment
• Train staff on hands-on tasks, as needed
• Serve as a safety representative, as needed
• Provide operational feedback and escalate issues observed
• Identify, recommend, and implement improvements related to routine functions
• Ability to work with different teams in an ever-changing, fast-paced environment
• Ability to maintain training and proficiency in supplemental assigned areas
• Enthusiasm for learning the different manufacturing areas and technologies at ARI

In this role, you will be expected to work a 12-hour shift (7AM-7PM) on a rotating schedule. This includes extra benefits such as built in overtime and getting premium pay for any Sundays worked. The schedule during the initial onboarding/training phase (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).

Agile Workforce and Cross-Area Support

• Support an agile manufacturing workforce by developing broader capabilities across assigned manufacturing areas and applying those skills where product demand, labor needs, and business priorities require
• Based on training, qualifications, and operational needs, move between areas to help address periods of peak demand and maintain effective production support across AR5 and AR30 manufacturing areas
• Work collaboratively with area teams and Front-Line Managers (FLMs) to align assignments with campaign needs and defined work durations
• Follow applicable training, qualification, GMP, and safety requirements when supporting work outside the primary area
• Use cross-area experience to contribute to problem solving, build technical depth, and support continuous improvement

Basic Qualifications

• 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 Qualifications

• Bachelor's degree in Science or Engineering
• Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
• Demonstrated foundational technical knowledge or transferable experience applicable to manufacturing, engineering, or operational environments
• Strong learning orientation with the ability to quickly develop technical proficiency in assigned areas
• Positive, collaborative attitude with a willingness to contribute to team success
• Ability to build effective working relationships across functions and with diverse stakeholders
• Demonstrated initiative by proactively seeking feedback, asking questions, and identifying learning opportunities
• Comfortable working in changing environments and adapting to evolving business priorities
• Strong organizational skills with the ability to remain focused on assigned responsibilities while managing competing priorities
• Demonstrated commitment to following established operational standards and procedures
• Ability to represent the organization professionally through collaboration, accountability, and customer-focused behaviors
• Willingness to accept coaching, demonstrate humility, and continuously improve through feedback
• 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
• 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