Hybrid Process Development Associate - Thousand Oaks, CA at Amgen

 

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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 Associate

What you will do and what we expect of you

Let’s do this. Let’s change the world. In this vital role you will:  

 Duties: Technical support of incoming method transfer/qualification, method optimization, troubleshooting method related issues, and investigations in an early phase GMP environment; Implementing and executing LC/CE methods as part of the product release testing, stability testing, characterization, method optimization, investigations, and regulatory submissions; 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; Experimental design and data interpretation, leveraging in-house visualization and analytics tools; and Communicating findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings). May telecommute.