Technical Specifications Manager – Raw Materials
Amgen
Summary
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. The position ensures specifications are scientifically accurate, compliant with regulatory and pharmacopeial requirements, and aligned with manufacturing and quality needs.
Job description
What you will do
- Author, revise, and maintain clinical and commercial raw material specifications and related controlled documents.
- Ensure specifications comply with cGMP requirements and pharmacopeial standards (USP, EP, JP).
- Translate technical, manufacturing, and regulatory requirements into raw material specifications.
- Manage specification lifecycle activities including new material introductions, revisions, periodic reviews, supplier changes, obsolescence activities, and implementation of approved changes.
- Partner with Process Development, Material Sciences, Engineering, Quality Assurance, Quality Control, Supply Chain, Regulatory Affairs, Manufacturing, and external suppliers.
- Facilitate specification review meetings and resolve technical issues.
- Support material qualification, technology transfers, investigations, supplier onboarding, and regulatory inspections as a specification SME.
- Drive continuous improvement, standardization, and digital transformation initiatives related to specification management and data quality.
Basic Qualifications
- Doctorate degree OR
- Master's degree and 2 years of related experience OR
- Bachelor's degree and 4 years of related experience OR
- Associate's degree and 8 years of related experience OR
- High school diploma / GED and 10 years of related experience
Preferred Qualifications
- Bachelor's or Master's degree in Chemistry, Biology, or related field.
- Experience with raw material specifications.
- Familiarity with PLM software.
- Quality experience preferred.
Requirements
- Doctorate degree OR Master's degree and 2 years of related experience OR Bachelor's degree and 4 years of related experience OR Associate's degree and 8 years of related experience OR High school diploma / GED and 10 years of related experience
- Bachelor's or Master's degree in Chemistry, Biology, or related field (preferred)
- Experience with raw material specifications (preferred)
- Familiarity with PLM software (preferred)
- Quality experience (preferred)
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-based Long-Term Incentives
- Time-off Plans
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.