Manufacturing Specialist – Single Use Systems (SUS) Lead

Career Category

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. 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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Manufacturing Specialist – Single Use Systems (SUS) Lead

What you will do

Let’s do this. Let’s change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC’s Manufacturing Support team, the Manufacturing Specialist will have ownership and oversight of Single Use Systems technology for the Manufacturing area, including generating training materials and / or providing training on scientific or technical aspects of the Single Use Systems. In addition, this role will have the opportunity to be involved on any of the following: Standard Operating Procedure (SOP) creation, review, and approval; develop, manage, and run change controls associated to area of expertise; and complete deviation investigations along with corresponding preventive/corrective action records. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to keep the manufacturing area operational.

• Provide technical support and subject matter expertise for Single Use Systems for the manufacturing area.
• Oversee and support ongoing development of all the manufacturing systems related to Single Use Systems including SOP, Training, Manufacturing Execution Systems/Batch Records, Quality Management System (e.g. Veeva/Trackwise) records, among others.
• Train staff (supervisors, operators, technical/QA/support) on Single Use systems.
• Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facility
• Facilitate process, area, and equipment risk assessments as needed to identify risks, failure modes, and mitigating actions
• Engage in regulatory inspections and in the NPI process to assess requirements for documentation, materials, training, and equipment modifications

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics DS manufacturing background with strong cross-functional project management and communication skills as well as the qualifications below.

Basic Qualifications:

• High school diploma / GED & 10 years of biotechnology operations experience OR
• Associate’s degree & 8 years of biotechnology operations experience OR
• Bachelor’s degree and 4 years of biotechnology operations experience OR
• Master’s degree in chemistry, biology or engineering and 2 years of biotechnology operations experience OR
• Doctorate degree

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
• Excellent cross-functional project management, meeting facilitation, and technical writing skills
• Experience in GMP manufacturing operations
• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing form