Specialist Manufacturing - Upstream DS

About the role

Join Amgens Mission of Serving Patients. At Amgen, if you feel like you are part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Responsibilities

• Support manufacturing by providing subject-matter expertise for drug substance upstream as process owner (PPO)
• Lead cross-function and complex projects using project management skills
• Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize process
• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
• Own Quality Records, such as CCMS, CAPA, and CAPA-EV
• Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant
• Demonstrate strategic problem-solving skills and champion continual improvement
• Present to inspectors on areas of expertise
• Mentor and train junior staff
• Ability to be on-site (flexible worker)
• Available to work various shifts (day, swing, graveyard, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations
• Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance

Qualifications

• Doctorate degree OR
• Masters degree and 2 years of manufacturing and or operations experience OR
• Bachelors degree and 4 years of manufacturing and or operations experience OR
• Associates degree and 8 years of manufacturing and or operations experience OR
• High school diploma / GED and 10 years of manufacturing and or operations experience