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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.  

Manufacturing Specialists (Multiple Positions)

Live

What you will do

Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and high performing teams? If you have a passion for talent development and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity.

Amgen, one of the world’s leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing “hub” known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls “FleX Batch” manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability; aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgen’s plan to be carbon neutral by 2027.

The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities, and office space. Amgen is targeting 2024 for site completion.

Let’s do this. Let’s change the world. In this vital role you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility. The Manufacturing Specialists will have process ownership and oversight of multiple manufacturing areas such as: Dispensing and Buffer/Media Preparation, Upstream Cell Culture, Harvest, and Downstream Purification. In this role, opportunities to be involved an any of the following: Standard Operating Procedure (SOP) creation, review, and approval; design, authoring, implementation, and validation of the electronic batch records; develop, manage, and run change controls associated to new product introductions (NPI); 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.

Responsibilities:

• Provide technical support and subject matter expertise for manufacturing area.
• Oversee support and ongoing development of all the manufacturing systems including SOP, TRNQ, MES, Trackwise records, among others.
• Train staff (supervisors, operators, technical/QA/support) on assigned manufacturing 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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications

Doctorate degree OR

Master’s degree and 3 years of biotechnology operations experience OR

Bachelor’s degree and 5 years of biotechnology operations experience OR

Associate’s degree and 10 years of biotechnology operations experience OR

High school diploma/GED and 12 years of biotechnology operations experience

Preferred Qualifications

• Educational background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering
• Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
• Proficient technical writing and presentation skills so as to communicate complex information effectively with technical and senior management staff
• Experience in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, engineering, supply chain, and quality