Technical Specifications Manager - Raw Materials
Amgen
August 20, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
Technical Specifications Manager – Raw Materials
Responsibilities:
- Author, revise, and maintain clinical and commercial raw material specifications and related controlled documents.
- Ensure specifications are scientifically accurate and compliant with cGMP, pharmacopeial requirements (USP, EP, JP), and internal quality requirements.
- Translate technical, manufacturing, and regulatory requirements into clear raw material specifications.
- Manage specification lifecycle activities (new material introductions, revisions, periodic reviews, supplier changes, obsolescence, and implementation of approved changes).
- Partner with Process Development, Material Sciences, Engineering, Quality, Supply Chain, Regulatory Affairs, Manufacturing, and external suppliers to develop/maintain specifications.
- Facilitate specification review meetings and drive resolution of technical issues.
- Support material qualification, technology transfers, investigations, supplier onboarding, and regulatory inspections as SME.
- Drive continuous improvement to enhance specification quality, consistency, efficiency, and compliance.
- Support standardization of templates, authoring practices, and lifecycle processes.
- Contribute to digital transformation and process improvement initiatives for better data quality.
Qualifications:
- Doctorate OR Master’s + 2 years OR Bachelor’s + 4 years OR Associate’s + 8 years OR High school/GED + 10 years (relative experience).
Preferred:
- Degree in chemistry, biology, or related field.
- Experience with raw material specifications.
- Familiarity with PLM software.
- Quality experience.
Benefits:
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application:
- Apply via careers.amgen.com; no application deadline; sponsorship not guaranteed.
Responsibilities:
- Author, revise, and maintain clinical and commercial raw material specifications and related controlled documents.
- Ensure specifications are scientifically accurate and compliant with cGMP, pharmacopeial requirements (USP, EP, JP), and internal quality requirements.
- Translate technical, manufacturing, and regulatory requirements into clear raw material specifications.
- Manage specification lifecycle activities (new material introductions, revisions, periodic reviews, supplier changes, obsolescence, and implementation of approved changes).
- Partner with Process Development, Material Sciences, Engineering, Quality, Supply Chain, Regulatory Affairs, Manufacturing, and external suppliers to develop/maintain specifications.
- Facilitate specification review meetings and drive resolution of technical issues.
- Support material qualification, technology transfers, investigations, supplier onboarding, and regulatory inspections as SME.
- Drive continuous improvement to enhance specification quality, consistency, efficiency, and compliance.
- Support standardization of templates, authoring practices, and lifecycle processes.
- Contribute to digital transformation and process improvement initiatives for better data quality.
Qualifications:
- Doctorate OR Master’s + 2 years OR Bachelor’s + 4 years OR Associate’s + 8 years OR High school/GED + 10 years (relative experience).
Preferred:
- Degree in chemistry, biology, or related field.
- Experience with raw material specifications.
- Familiarity with PLM software.
- Quality experience.
Benefits:
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application:
- Apply via careers.amgen.com; no application deadline; sponsorship not guaranteed.