Specialist Manufacturing: Manufacturing Execution System (MES)

What you will do In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC’s Manufacturing Support team you are responsible for ensuring all Electronic Batch Records accurately document the manufacturing process and for driving batch record optimization between the manufacturing floor and the global MES team. Coordinate with Global MES Team, Manufacturing, Process Development, Process Owner, and Quality to create and modify electronic batch records to support new product and technology implementation. Lead and/or participate in projects, ensuring batch records record all necessary process data for unit operations in Koerber PAS|X. Support manufacturing in troubleshooting, problem solving, and root cause analysis. Support CAPA development to prevent error recurrence. Own Generic Master Batch Record (GMBR) optimizations and act as primary liaison between site MES and global MES team. Respond to regulatory questions and audit findings. Champion Lean Transformation and Operational Excellence initiatives, facilitate continuous improvement, and track plant-level progress. Support batch record standardization to enable network-wide use of generic batch records. What we expect of you We seek a manufacturing professional with a biologics drug substance manufacturing background, strong cross‑functional project management skills, and excellent communication abilities. Basic Qualifications Doctorate degree OR Master’s degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience 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 bioprocessing disciplines Extensive experience with electronic batch record design in Koerber PAS|X or comparable software Ability to communicate complex technical information effectively in both presentation and technical writing forms Ability to coach, mentor, and cross‑train colleagues within core technical areas What you can expect of us Salary: Annual base salary range in the U.S. is provided below. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans, financial plans, work/life balance, and career development opportunities. Benefits include: Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions Group medical, dental and vision coverage for staff and eligible dependents Life and disability insurance Flexible spending accounts Discretionary annual bonus program; 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. Salary Range: USD - USD #J-18808-Ljbffr Amgen Inc. (IR)