Sr. Specialist Manufacturing

Career Category Operations Job Description

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.

What you will do Let’s do this. Let’s change the world. In this critical individual contributor role, you will report to the Senior Manager of Manufacturing Support Investigations and provide technical leadership for complex major deviation investigations. You will influence cross‑functional teams, drive science and risk‑based decision making, and advance operational excellence through technical expertise, strategic problem solving, and continuous improvement.

• Serve as the technical lead and Major Deviation Owner for the site’s most complex, high‑impact, and regulatory‑significant investigations, providing strategic direction from initiation through closure.
• Establish a strong operational presence by leading in‑field investigation activities, coaching investigation teams, and driving rigorous fact‑finding to ensure high‑quality, science‑and risk‑based outcomes.
• Act as a recognized subject matter expert, advancing organizational technical capability through mentoring, knowledge sharing, and application of advanced investigation methodologies.
• Drive cross‑site and network standardization by partnering with investigation leaders and quality organizations to align practices, share lessons learned, and implement enterprise best practices.
• Represent the organization as the technical authority during internal audits, regulatory inspections, and health authority interactions, providing expert defense of investigation strategy, rationale, and compliance decisions.
• Identify and lead strategic continuous improvement initiatives that enhance investigation effectiveness, quality systems, and operational performance, including the evaluation, implementation, and governance of AI‑enabled investigation tools and digital solutions.
• Influence quality strategy by identifying systemic trends, recommending risk‑based solutions, and driving sustainable improvements that strengthen product quality, inspection readiness, and regulatory compliance across the organization.
• Lead complex, cross‑functional problem‑solving efforts involving Manufacturing, Engineering, Process Development, Quality Control, Supply Chain, and Regulatory Affairs to resolve critical quality issues and enable business continuity.
• Champion a culture of operational excellence by leveraging data analytics, quality metrics, and emerging technologies to proactively identify risks, improve decision‑making, and optimize investigation processes.

We are all different, yet we all use our unique contributions to serve patients. The dedicated…