Career Category

Manufacturing

Job Description

The Associate Manufacturing is a hands-on role in the AR30 team, focused on operational readiness and start-up.

The on-boarding phase for this role will last 2-8 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7AM-7PM with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay.

Under general supervision, Associate will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs). Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent their functional area. Associate may also have the responsibility of owning deviations/CAPAs. In addition, Associate may identify, recommend, and implement improvements related to routine functions.

Basic Qualifications :

• Bachelor’s degree
• OR
• Associate’s degree and 4 years of Manufacturing or Operations experience
• OR
• High School diploma/GED and 6 years of Manufacturing or Operations experience.

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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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