Associate Manufacturing (Pilot Plant)

Career Category

Operations

Job Description

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Associate Manufacturing (Pilot Plant)

Let’s do this. Let’s change the world. In this vital role you will support the execution of cell culture, harvest, and purification process studies at the 500L scale, to include operation of single-use bioreactors, centrifugation equipment, chromatography skids and filtration systems. The Amgen Rhode Island AR6 Pilot Plant provides critical technical support for team supply, commercial process development, technology transfer, process characterization, and scale-up/scale-down activities.

This is a day shift position that includes off shift and weekend coverage.

Role Responsibilities:

• Aseptically maintain mammalian cell culture through vial thaw, flask passaging, bioreactor operations to harvest, which may include, but not limited to; centrifugation, multistage clarification and/or ATF (Alternating Tangential Flow) filtration
• Protein purification via multi-stage chromatography and filtration systems to include, but not limited to; Ion-Exchange Chromatography (IEX), Affinity Chromatography and Tangential Flow Filtration
• Set-up and operation of bioreactors and vessels, centrifugation and filtration harvest equipment and downstream equipment to include, but not limited to; chromatography and Ultra Filtration Diafiltration (UF/DF) skids
• Perform bench-work studies such as titration and filtration
• Perform in-process sampling and monitoring
• Analyze in-process samples and perform routine analytical equipment maintenance
• Perform batch and filtration of media and buffers
• Perform new product introductions (NPI), technology transfer and participate in equipment or experiment design
• Perform documentation of experimental data in electronic lab notebooks in accordance with Good Laboratory Practices (GLP)
• Perform general lab organization and cleaning
• Management of inventory, operational excellence (OE) initiatives and preventative maintenance for systems and equipment
• Inform-role for operational decision making, troubleshooting and investigative work.

Basic Qualifications:

• Bachelor’s degree OR
• Associate’s degree + 6 months of biotechnology in manufacturing, engineering, or process development work experience OR
• High school diploma / GED + 2 years of biotechnology in manufacturing, engineering, or process development work experience

Preferred Qualifications:

• An established record of encouraging safety in a lab or manufacturing setting
• Experienced in performing bioprocess unit operations in cell culture and/or purification
• Knowledge in troubleshooting process equipment issues including automation control strategies and utilities such as clean in place (CIP) and clean steam
• Experience in the operation of control systems (Delta V) and method development on Cytiva purification systems using Unicorn
• Experience with data analysis and interpretation
• Experience collaborating with and across functional areas and sites
• Strong written and verbal communication skills; strong computer skills
• Experience in leading Operational Excellence (OE) efforts to drive efficiency and safety

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

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