Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Live

What you will do

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

Job Description

As a Specialist Stability you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.

The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections. Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential.

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

Key Responsibilities include:

• Build and maintain technical GMP documents and product stability studies

• Review, verify, report, and archive GMP data for clinical and commercial products

• Apply keen attention to detail to conduct data review and reports

• Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)

• Adeptly manage time-sensitive activities independently

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.

Basic Qualifications

• Doctorate degree, or

• Master’s degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or

• Bachelor’s degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience or

• Associates degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience or

• Highschool diploma / GED and 12 years of of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications

• B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment

• Experience working in a regulated environment (either direct GMP or technical support)

• Strong project management skills

• Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques

• General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceuticals

• Experience working on a cross-functional team in a matrix environment

• Excellent written and verbal communication skills, including facilitation and presentation skills

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

#Operations21

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.