Technical Specifications Manager - Raw Materials

About the role

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 world’s toughest diseases. With a 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.

Responsibilities

• Author, revise, and maintain clinical and commercial raw material specifications and related controlled documents.
• Ensure specifications are scientifically accurate, compliant with cGMP, pharmacopeial (USP, EP, JP), and internal quality requirements.
• Translate technical, manufacturing, and regulatory requirements into clear and effective raw material specifications.
• Manage specification lifecycle activities, including new material introductions, revisions, periodic reviews, supplier changes, obsolescence, and implementation of approved changes.
• Partner with Process Development, Material Sciences, Engineering, Quality Assurance, Quality Control, Supply Chain, Regulatory Affairs, Manufacturing, and external suppliers to develop and maintain raw material specifications.
• Facilitate specification review meetings, drive resolution of technical issues, and ensure timely completion of action items.
• Support material qualification, technology transfers, investigations, supplier onboarding, and regulatory inspections as the specification subject matter expert.
• Identify and implement opportunities to improve specification quality, consistency, efficiency, and compliance.
• Support standardization of specification templates, authoring practices, and lifecycle processes.
• Contribute to digital transformation and process improvement initiatives that enhance specification management and data quality.

Requirements

• Doctorate degree OR
• Master’s degree and 2 years of relative experience OR
• Bachelor’s degree and 4 years of relative experience OR
• Associate’s degree and 8 years of relative experience OR
• High school diploma / GED and 10 years of relative experience

Qualifications

• Bachelor’s or master’s degree in chemistry, biology, or related subject
• Experience with raw materials specifications
• Familiarity with PLM software (product lifecycle management)
• Quality experience is a plus

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.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
• Group medical, dental, and vision coverage
• Life and disability insurance
• Flexible spending accounts
• 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