Raw Materials Specifications Leader

amgen; Thousand Oaks (CA); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Retirement plan

Flexible work models

Job summary

Amgen in Thousand Oaks, CA is seeking a Technical Specifications Manager – Raw Materials to lead development, implementation, maintenance, and lifecycle management of raw material specifications and related documents. The role ensures specifications are scientifically accurate, regulatory compliant, and aligned with manufacturing and quality standards.

The position requires cross‑functional collaboration with Process Development, Material Sciences, Engineering, QA, QC, Supply Chain, Regulatory

Qualifications

• Bachelor’s or Master’s degree in chemistry, biology, or related field with relevant experience.
• Experience drafting and maintaining raw material specifications.
• Familiarity with regulatory requirements (cGMP, USP, EP, JP) is preferred.

Responsibilities

• Develop, implement, maintain, and lifecycle manage raw material specifications and related documents.
• Collaborate with Process Development, Engineering, Quality Assurance, and Regulatory Affairs to ensure compliance.
• Lead specification lifecycle activities including introductions, revisions, reviews, supplier changes, and obsolescence.
• Drive continuous improvement to improve specification quality and data integrity.

Skills

Raw materials specifications

Quality experience

Regulatory/compliance awareness

Education

Bachelor’s or Master’s degree in chemistry, biology, or related subject

Tools

PLM software

Job description

Amgen in Thousand Oaks, CA is seeking a Technical Specifications Manager – Raw Materials to lead development, implementation, maintenance, and lifecycle management of raw material specifications and related documents. The role ensures specifications are scientifically accurate, regulatory compliant, and aligned with manufacturing and quality standards.

The position requires cross‑functional collaboration with Process Development, Material Sciences, Engineering, QA, QC, Supply Chain, Regulatory