Stability Specialist

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

What you will do

Let’s do this. Let’s change the world. In this vital role 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 on projects, issue resolutions and investigations. You will work closely with diverse functional groups including: Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development.

Responsibilities:

• 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strong communicator with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Associate’s degree and 8 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Bachelor’s degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Master’s degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Doctorate degree

Preferred Qualifications:

• Bachelor 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

What you can expect of 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 $109,307.00 to $129,509.00. 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, including remote and hybrid work arrangements, where possible

Apply now for a career that defies imagination

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