Technical Specifications Manager - Raw Materials

Career Category

Operations

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.

Technical Specifications Manager – Raw Materials

Let’s do this. Let’s change the world. In this vital role you will be responsible for the development, implementation, maintenance, and lifecycle management of clinical and commercial raw material specifications and related controlled documents. This role ensures specifications are scientifically accurate, compliant with regulatory and pharmacopeial requirements, and aligned with manufacturing processes and quality standards. The Technical Specifications Manager works closely with Process Development, Material Sciences, Engineering, Quality Assurance, Quality Control, Supply Chain, Regulatory Affairs, and external suppliers to translate technical and manufacturing requirements into clear, compliant, and effective raw material specifications.

The role also identifies and drives continuous improvement initiatives to enhance specification quality, standardization, efficiency, and compliance across the specification lifecycle.

• 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.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications:

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

Preferred Qualifications:

• Bachelor’s or master’s degree in chemistry, biology, or related subject

• Experience with raw materials specifications

• Familiarity with PLM software (product lifecycle…