Sr. Specialist Manufacturing

At Amgen, 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 toughest diseases. With a focus on 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-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.

Responsibilities

• 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.

Requirements

Basic Qualifications

• High school diploma / GED and 12 years of Quality and/or Manufacturing experience
• Associate’s degree and 10 years of Quality and/or Manufacturing experience
• Bachelor’s degree and 6 years of Quality and/or Manufacturing experience
• Master’s degree and 4 years of Quality and/or Manufacturing experience
• Doctorate degree and 2 years of Quality and/or Manufacturing experience

Preferred Qualifications

• Demonstrated expertise in deviation management systems, root cause investigations, CAPA strategy, and quality system processes within a GMP-regulated environment.
• Experience serving as a technical representative during internal audits and regulatory inspections, including presenting and defending investigation records and quality decisions.
• Proven ability to lead complex, cross-functional projects, effectively balancing multiple priorities while delivering high-quality results within established timelines.
• Exceptional written, verbal, and presentation skills, with the ability to influence stakeholders, facilitate technical discussions, and communicate complex concepts with clarity and urgency.
• Demonstrated ability to build trusted partnerships and influence cross-functional teams without formal authority to drive alignment and achieve business objectives.

Benefits

• A comprehensive employee benefits package, including:
  • Retirement and Savings Plan with generous company contributions
  • Group medical, dental, and vision coverage
  • Life and disability insurance
  • 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 where possible

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.