Process Development Sr. Associate, Assay Development

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. 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.

Process Development Sr. Associate, Assay Development

What you will do

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

• Developing and implementing innovative and fit-for-purpose analytical methods for: impurity release testing.

• Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions.

• Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions.

• May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation.

• Keeps current in analytical development field including literature and technology development for groundbreaking and regulatory driven activities.

• Supporting analytical projects involving method development, qualification, and transfer.

• Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions.

• Innovation – positive approach to challenges; champions new insights and initiatives; brings out and utilizes others’ creativity to improve unit performance.

• Client orientation– establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered.

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 an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 6 years of Scientific experience OR

• Associate’s degree and 4 years of Scientific experience OR

• Bachelor’s degree and 2 years of Scientific experience OR

• Master’s degree

Preferred Qualifications:

• Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.

• Experience with automation platforms, specifically large scale liquid handlers.

• Experience and expertise with the use of electronic notebooks, as well as Microsoft Office software, particularly Word, PowerPoint and Excel.

• Experience working in a GMP regulated environment, as well as with regulatory filings (IND, BLA, and NDA) and ICH Guidelines.

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 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 fi