Process Development Associate – Large Molecule Release Testing, Pre-Pivotal Attribute Science

Career Category

Operations

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Associate – Large Molecule Release Testing, Pre-Pivotal Attribute Science

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for defining the critical quality attributes of Amgen’s therapies and advancing innovative analytical tools to support their development.

• Good understanding of cGMP principles and follow compliance requirements in routine day to day work.

• Technical support of incoming method transfer/qualification, method optimization, troubleshooting method related issues, and investigations in an early phase GMP environment.

• Implementing and executing compendial methods (Protein conc, pH, Osmolarity, color, clarity etc), chromatography and capillary electrophoresis methods as part of the product release testing, stability testing, characterization, method optimization, investigations, and regulatory submissions

• Documenting all experiments following Good Documentation Practices. Generating, analyzing, and critical evaluation of analytical data to support product release and stability, process characterization, investigations, and regulatory submissions

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

• Routine laboratory maintenance such as restocking, ordering, and assistance in safety actions and audit readiness.

• Maintaining and updating monthly Work Order (WO) tracking for PM and calibration activities using Maximo.

• Managing reagents freezer inventory through detailed manual counts and maintenance of inventory tracking records.

• Coordinating monthly pipette calibration, including collection, verification of WO closure, and initiation of HLEE investigations for out-of-tolerance results.

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 leader with these qualifications.

Basic Qualifications:

Bachelor’s degree

OR

Associate’s degree and 2 years of operations experience

OR 

High school diploma / GED and 4 years of operations experience

Preferred Qualifications:

• B.S.  Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related technical subject area

• Demonstrated ability in the biotech industry, including but not limited to GxP regulations.

• Experience in compendial techniques, chromatography and capillary electrophoresis techniques.

• Experience developing, qualifying, and testing analytical methods.

• Excellent documentation skills, including an understanding of GxP requirements.

• Excellent communication (oral and written) skills and attention to detail.

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 sa