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Join Amgen’s Mission of Serving Patients. 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
Job Responsibility
Serve as the technical SME for visual inspection and provide leadership in troubleshooting complex inspection-related issues
Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management
Own and continuously improve the business process for defect kit preparation and management supporting visual inspection development studies
Establish testing strategies and develop characterization protocols, offline testing methods, and product quality impact assessments for product teams
Interface with inspection teams across Amgen manufacturing sites and communicate site capabilities, best practices, and lessons learned
Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes
Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management
Apply basic science/engineering skills and first principles modeling to solve technical problems
Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software
Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs
Conducts risk assessment for inspection operations and propose / implement appropriate CAPA
Identifies and implements operational opportunities for current and new inspection operations
Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management
Development of Validation Plans, IOQs and PQs
Ensure that inspection operations meet applicable quality requirements applicable laws FDA, EU & International Standards
Assist in deviation and exception resolution and root cause analysis
Coordinates and organizes resources needed to complete tasks
Requirements
Doctorate Degree OR Master's Degree and 2 years of Engineering and/or Operations experience OR Bachelor's Degree and 4 years of Engineering and/or Operations experience OR Associate's degree and 8 years of Engineering and/or Operations experience OR High school diploma/GED and 10 years of Engineering and/or Operations experience
PhD with 2 years of industry experience
Background industry with development and manufacturing visual inspection experience
Experience with Knapp studies
Experience in packaging and inspection equipment
Previous experience with Pharma inspection background
What we offer
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