Career Category

Job Description

Amgen is currently seeking a Process Development Sr Scientist in our Pre-Pivotal Attribute Sciences Department in Thousand Oaks, CA. Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the critical quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pre-Pivotal AS organization’s focus is on supporting analytical method development and product characterization to advance candidates from research to first-in-human clinical trials.

The Process Development Sr Scientist will contribute to Amgen’s diverse early-stage portfolio of therapeutic modalities with a focus on understanding process and product properties of large molecule drug candidates and assessing the quality attributes of protein therapeutics being developed across multiple therapeutic areas in Amgen’s pipeline. The candidate will be responsible for analytical leadership of pre-pivotal programs and the implementation of sophisticated analytical techniques to characterize novel modalities in the pipeline.

Key responsibilities:

• Routinely craft experiments that lead to a fundamental understanding of a therapeutic protein’s attributes and stability characteristics.
• Development and optimization of analytical methods (HPLC/UPLC, CE and mass spec) to support lead candidate selection for different modalities at the molecule assessment stage, to improve method performance and to increase efficiency and throughput.
• Investigation of method performance, reliability, and evaluation of impact of proposed changes.
• Deep understanding of product quality attributes and methodology to measure attributes, and to ensure proper control strategy.

• Optimally function as an Attribute Sciences lead on project teams and participate in technology transfer activities
• Support drug substance and drug product process development, and protein characterization
• Authoring regulatory documents. Understanding of regulatory expectations for analytical methods, control and stability strategy and comparability.
• Work collaboratively with other scientists on multidisciplinary teams
• Keep current with field of expertise and evaluate emerging analytical technology

Basic Qualifications:

• Doctorate degree plus 2 or more years of industry experience OR
• Master’s degree and 5 years of directly related life science experience OR
• Bachelor’s degree and 7 years of directly related life science experience

Preferred Qualifications

• Ph.D. in biochemistry, chemistry or other life science area plus 4 or more years of industry experience.

• Strong lab skills to design and execute scientific experiments, interpretation of complex data and deliver results
• Strong expertise in analytical method development, validation and trouble-shooting for using HPLC/UPLC, CE and mass spectrometry etc.

• Strong proven experience in separation sciences, protein chemistry and/or mass spectrometry.

• Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as fragmentation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools
• Prior experience authoring or contributing to regulatory filings.
• Work independently in advancing projects and studies within required deadlines.
• Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary environment.