Raw Materials Specifications Lead

Amgen SA; Thousand Oaks (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Retirement and Savings Plan

Job summary

Amgen seeks a Technical Specifications Manager – Raw Materials to lead development, maintenance, and lifecycle management of clinical and commercial raw material specifications and related documents. You will ensure scientifc accuracy, cGMP compliance, and alignment with manufacturing and quality standards.

The role requires collaboration with Process Development, Quality Assurance, Regulatory Affairs, and external suppliers to drive continuous improvement and standardization across

Qualifications

• Doctorate degree in a relevant field with related experience.
• Bachelor’s degree and 4 years of relative experience.
• Associate’s degree and 8 years of relative experience.
• High school diploma / GED with 10 years of relative experience.

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.

Skills

Experience with raw materials specs

Quality experience

Education

Doctorate degree

Master’s degree with 2 years relative experience

Bachelor’s degree with 4 years relative experience

Associate’s degree with 8 years relative experience

High school diploma / GED with 10 years relative experience

Tools

PLM software

Job description

Amgen seeks a Technical Specifications Manager – Raw Materials to lead development, maintenance, and lifecycle management of clinical and commercial raw material specifications and related documents. You will ensure scientifc accuracy, cGMP compliance, and alignment with manufacturing and quality standards.

The role requires collaboration with Process Development, Quality Assurance, Regulatory Affairs, and external suppliers to drive continuous improvement and standardization across