Raw Materials Specifications Leader

BioSpace; Thousand Oaks (CA); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Health benefits

Stock-based incentives

Flexible work models

Competitive retirement plans

Job summary

Amgen is seeking a Technical Specifications Manager Raw Materials to own and maintain clinical and commercial raw material specifications. You will ensure scientific accuracy, regulatory compliance, and lifecycle management across processes and quality standards.

You will work with Process Development, Engineering, QA, QC, Regulatory Affairs, Supply Chain, and suppliers to align requirements and drive continuous improvement.

Qualifications

• Doctorate degree required.
• Multiple education routes with relevant experience considered.
• Experience with raw materials specifications is preferred.
• Familiarity with PLM software is a plus.

Responsibilities

• Author, revise, and maintain clinical and commercial raw material specifications and related controlled documents.
• Ensure specifications are scientifically accurate and compliant with regulatory and pharmacopeial requirements.
• Translate technical, manufacturing, and regulatory requirements into clear raw material specifications.
• Manage specification lifecycle activities including new materials, revisions, and supplier changes.
• Collaborate with cross-functional teams to develop and maintain specifications.

Education

Doctorate degree

Masters degree with 2 years of experience

Bachelors degree with 4 years of experience

Associates degree with 8 years of experience

High school diploma / GED with 10 years of experience

Tools

PLM software

Job description

Amgen is seeking a Technical Specifications Manager Raw Materials to own and maintain clinical and commercial raw material specifications. You will ensure scientific accuracy, regulatory compliance, and lifecycle management across processes and quality standards.

You will work with Process Development, Engineering, QA, QC, Regulatory Affairs, Supply Chain, and suppliers to align requirements and drive continuous improvement.