Manufacturing Specialist Single Use Systems (SUS) Lead

Manufacturing Specialist Single Use Systems (SUS) Lead Join to apply for the Manufacturing Specialist Single Use Systems (SUS) Lead role at BioSpace What You Will Do Lets do this. Lets 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 in: SOP creation, review, and approval; develop, manage, and run change controls associated to area of expertise; and complete deviation investigations along with corresponding CAPA 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 records (e.g. Veeva/Trackwise), among others. Train staff on Single Use Systems. Support troubleshooting during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facility. Facilitate process, area, and equipment risk assessments 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 and 10 years of biotechnology operations experience OR Associates degree and 8 years of biotechnology operations experience OR Bachelors degree and 4 years of biotechnology operations experience OR Masters 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 will support your journey every step of the way. In addition to the base salary, Amgen offers competitive total rewards plans aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr BioSpace