Manufacturing Specialist Single Use Systems (SUS) - Holly Springs, NC

Manufacturing Specialist Single Use Systems (SUS) - Holly Springs, NC

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

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 forms

Ability to coach, mentor and/or cross train colleagues within core technical areas

Background in lean manufacturing methodologies and operational excellence

Strong technical knowledge of Single Use System use at a drug substance company and a broad understanding of related disciplinary areas in bioprocessing

Proficient technical writing and presentation skills 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

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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.