Process Development Senior Associate - Cellular Sciences - Biosafety Development Group

Overview

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 Senior Associate - Cellular Sciences - Biosafety Development Group

In this vital role you will join our Biosafety Development (BSD) group. The Senior Associate will support ensuring patient safety by performing sterile filtration validation studies for Amgen's pharmaceutical products. They may partake in technology development for detection and identification of bacterial adventitious agents. Primary focus will be on performing GMP validation studies for sterile filtration via Standard Operating Procedures and qualified detection methods using model bacterial strains.

These studies will support IND and MA filings to the FDA. Test articles are generated with protein purification processes and will require preliminary testing to assess matrix interference with bacterial health. Assays performed for the detection of bacteria may include traditional detection methods and/or molecular techniques.

• Leading and executing GMP bacterial filtration retention studies to support IND and MA filings to the FDA.
• Utilizing traditional or molecular assays for the detection of bacterial adventitious agents.
• Applying filtration knowledge and techniques to troubleshoot problems during execution of studies.
• Assay method development and qualification.
• Training other employees.
• Managing materials and supply inventory.

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these 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

• Hands on experience with purification processes, especially filtration. Previous work assessing and validating filtration loading and performance using small-scale model devices is desired.
• Hands on experience with bacterial detection techniques, including molecular biology methods (e.g., qPCR); method development experience a plus.
• Possess strong written and verbal communication skills and a desire to learn new scientific concepts.
• Work as a member of a small team to follow and develop methods.
• Demonstrate good planning and project execution skills.
• Clearly and concisely interpret and present data.
• Ability to understand, apply and evaluate biological and mathematical principles.
• Excellent sterile technique.

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…