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
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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
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.
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.
We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.
