Process Development Sr Associate - Pivotal Attribute Sciences

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 - Pivotal Attribute Sciences

What you will do

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

Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), live oncolytic viruses, and synthetic medicines.

As a PD Sr Associate, the candidate will participate in protein characterization studies to support regulatory filings using high/ultra-high performance liquid chromatography (HPLC/UHPLC), capillary electrophoresis (CE), and mass spectrometry (MS). The candidate will also work to develop, qualify, and transfer analytical methods to Quality Control, and optimize and troubleshoot existing methods. They will interface with other process development departments to support commercial process development and process characterization studies in support of marketing applications.

This position is located at our Thousand Oaks, CA office.

Key responsibilities:

• Perform method development and qualification studies using HPLC, UHPLC, and CE platforms

• Perform chromatographic fractionation, peptide mapping, intact mass, and other LC-MS studies to support product characterization and comparability studies

• Author results in laboratory notebooks and method development reports, interfacing closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods

• Participate in the maintenance of Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase-appropriate good manufacturing practices (GMP) environment

• With a focus toward evaluation of critical quality attributes, coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions

• Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways

• Perform evaluation of novel platform analytical technologies to help drive innovation

• Perform experiments to help answer questions from health authorities

• Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications

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:

• Scientific background in method development and product characterization for therapeutic proteins

• Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects

• A self-starter, and someone who values working in teams

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. Fro