Process Development Associate

What you will do

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

As a PD Associate, the candidate will participate in protein characterization studies to support regulatory filings using Capillary Electrophoresis (CE), High Performance Liquid Chromatography (HPLC) / Ultra Performance Liquid Chromatography (UPLC) 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 collaborate 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 site.

Key responsibilities:

• Perform method development and qualification studies using HPLC, UPLC, 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:

• Master's degree
• Bachelor's degree 2 years of Scientific experience OR Associate's degree and 4 years of Scientific experience OR High school diploma / GED and 6 years of Scientific experience

Preferred Qualifications:

• Scientific background in method development and product characterization for therapeutic proteins
• Preferred Degree in Biochemistry, Analytical Chemistry, Protein Chemistry or related subject area
• Excellent written and verbal communication skills, ability to multitask, efficiently plan and follow through on complex projects
• A self-starter, and someone who values working in teams