Amgen-posted 3 months ago
Full-time • Entry Level
Hybrid • Thousand Oaks, CA
Chemical Manufacturing

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

  • Initiate, revise, and approve manufacturing-controlled documents in the document management system.
  • Serve as document author, owner, reviewer, or data verifier as needed, ensuring all controlled documents accurately reflect current operations and compliance standards.
  • Implement new product introductions and major projects within Drug product (DP) operations.
  • Collaborate with Capital and cross-functional teams to define requirements, develop operational strategies, and implement deliverables, including procedures, batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation, training, and floor readiness.
  • Analyze floor operations data and observations to identify root causes of deviations or inefficiencies.
  • Develop and implement data-driven solutions to drive process improvements and enhance operational performance.
  • Ensure timely investigation and resolution of deviations within established goals.
  • Perform deviation assessments, support root cause analysis (RCA), human performance evaluations, and CAPA development.
  • Monitor CAPA effectiveness to prevent recurrence and take additional corrective actions as needed.
  • Assist in the development and execution of process validation protocols and reports.
  • Collect, analyze, and interpret process validation data to ensure compliance and operational robustness.
  • Support the establishment of process monitoring parameters and control limits, ensuring timely execution of process performance or validation reports and deviation assessments.
  • Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements.
  • Support monitoring initiatives by configuring applicable requirements in MBRs/GMBRs and data monitoring applications (e.g., Enterprise Data Lake, Spotfire).
  • Ensure configurations align with process design, GMP requirements, and Amgen guidelines.
  • Work closely with process owners, process development, and automation teams to design and implement new processes or modifications.
  • Assess, prioritize, justify, and support implementation of process or equipment modifications, providing project management support.
  • Participate in the assessment and execution of special projects or initiatives to enhance manufacturing operations.
  • Doctorate degree
  • Or Master's degree and 2 years of Manufacturing support experience
  • Or Bachelor's degree and 4 years of Manufacturing support experience
  • Or Associate's degree and 8 years of Manufacturing support experience
  • Or High school diploma / GED and 10 years of Manufacturing support experience
  • Educational background in Life Sciences and/or Engineering.
  • In-depth experience of Drug Product Manufacturing.
  • Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why's)
  • Familiar with Lean Manufacturing Practices
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Proficiency in GDP (Good Documentation Practices) on a regulated environment
  • Knowledge in systems: EBR, Trackwise, Spotfire, CDOCS, and process monitoring platforms
  • Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English
  • A 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
  • Flexible work models, including remote and hybrid work arrangements, where possible
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