Senior Associate Manufacturing - Solutions Prep and Upstream Support Proces

at  Amgen

JOIN AMGEN’S MISSION OF SERVING PATIENTS

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

BASIC QUALIFICATIONS:

• High school diploma / GED and 4 years of Manufacturing or Operations work experience OR
• Associate’s degree and 2 years of Manufacturing or Operations work experience OR
• Bachelor’s degree and 6 months of Manufacturing or Operations work experience OR
• Master’s degree

PREFERRED QUALIFICATIONS:

• Single use technology experience
• Solutions Preparation and/or Cell Culture Experience (troubleshooting critical processes)
• Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment (Deviation / Nonconformance investigation writing experience)
• Understanding of analytical methods used for manufacturing area
• Regulatory knowledge and experience with regulatory audits
• Ability to interpret and apply GMP knowledge
• Knowledge of WIP lab equipment and computers, with LIMS access
• Statistical and mathematical skills
• Ability to demonstrate technical writing capability
• Able to demonstrate project management skills and presentation skills
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Experience with Delta V/MES
• Experience with lab equipment/testing

Let’s do this. Let’s change the world. In this vital role you will join the manufacturing technical support function in Amgen Rhode Island. Next Generation Bio Manufacturing plant AR30 is responsible for drug substance and the release of Amgen’s commercial product using innovative single use manufacturing platforms and technologies.

Responsibilities include:

• Interact broadly across the site/plant to implement key business deliverables, quality initiatives, and continuous improvement projects
• Support in developing Training Material, SOP’s, Electronic Batch Records, Job Hazard Analysis, and Standard Work
• Participate in commissioning and qualification of process equipment
• Facilitate problem solving and root cause investigations in a biotechnology environment