Technical Specifications Manager – Raw Materials

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Technical Specifications Manager - Raw Materials

What you will do

Let’s do this. Let’s change the world. 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.

• 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

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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.

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