Specialist Manufacturing: Manufacturing Execution System (MES)

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role. 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. Specialist Manufacturing: Manufacturing Execution System (MES) What you will do 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, this position is responsible for ensuring all Electronic Batch Records accurately document the manufacturing process. It is a highly visible role across the site with the core responsibility of driving batch record optimization between the manufacturing floor and the global MES team. This role will also offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved productivity on the manufacturing floor. Manufacturing Execution System (MES) Specialist coordinating with Global MES Team, Manufacturing, Process Development, Process Owner, and Quality to create and modify electronic batch records to support the implementation of new products and/or technologies into the plant. Subject Matter Expert who leads and/or participates in projects, ensuring that electronic batch records accurately and effectively record all necessary process data for unit operations in Koerber PAS|X. Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence. Owns Generic Master Batch Record (GMBR) optimization and functions as the primary liaison between the site MES and global MES team to drive on time deliveries of the GMBRs. Responds to regulatory questions and/or audit findings. Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level. Support batch record Standardization to enable network wide usage of generic batch records. 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 Drug Substance manufacturing background with strong cross‑functional project management and communication skills as well as the below qualifications. Basic Qualifications Doctorate degree OR Master’s degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or Bachelor’s degree and 5 years of biotechnology operations experience Associate’s degree & 10 years of biotechnology operations experience High school diploma / GED & 12 years of biotechnology operations experience 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 Strong technical knowledge of drug substance processing (inoculation, bioreactors, harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing. Extensive experience with electronic batch record design in Koerber PAS|X or comparable software for electronic batch records with some understanding of editing and validation 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 What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well‑being. The annual base salary range for this opportunity in the U.S. is provided below. In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan. Stock‑based long‑term incentives. Award‑winning time‑off plans and bi‑annual company‑wide shutdowns. Flexible work models, including remote work arrangements, where possible. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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 Amgen SA