Process Development Associate Scientist

Amgen•Thousand Oaks, CA

About The Position

The Process Development Associate Scientist performs sample preparation, analytical testing, method development, and characterization using biophysical and spectroscopic techniques, including infrared (IR) spectroscopy, circular dichroism (CD) spectroscopy, UV-visible spectroscopy, and differential scanning calorimetry (DSC) for thermal stability analysis. This work supports product and process characterization and regulatory submissions. Experience with high-performance liquid chromatography (HPLC) for protein analysis is desired. The associate characterizes higher-order structure and aggregation-related attributes of biologics in support of product characterization, comparability and similarity studies, technology development, and non-routine investigations. The role also involves complex data analysis and interpretation, troubleshooting, preparing technical reports and presentations, and developing acceptance criteria. Success requires strong scientific and analytical skills, effective collaboration across multidisciplinary and cross-functional teams, and adaptability in a fast-paced environment with changing priorities.

Requirements

Bachelor’s degree; or an associate degree and 2 years of experience in chemistry, biochemistry, biotechnology, physics, or a related field; or a high school diploma/GED and 4 years of experience in those fields.
Strong scientific, laboratory, and analytical skills.
Ability to design and execute scientific experiments, analyze data, interpret results, and maintain accurate laboratory records.
Ability to collaborate effectively with multidisciplinary and cross-functional teams.
Strong technical communication skills, including preparing reports, presentations, and documentation supporting regulatory activities.
Ability to work independently, manage multiple priorities, and adapt to evolving project needs and timelines.

Nice To Haves

Two or more years of experience directly related to biophysical characterization of proteins, including hands-on use of IR, CD, UV-visible spectroscopy, and DSC for thermal stability analysis.
Hands-on experience with HPLC systems for protein separation and characterization.
Experience developing, qualifying, and/or validating analytical methods.
Experience analyzing and interpreting complex data and establishing acceptance criteria for product comparability and similarity studies.

Responsibilities

Perform sample preparation, analytical testing, method development, and characterization using biophysical and spectroscopic techniques.
Characterize higher-order structure and aggregation-related attributes of biologics for product characterization, comparability and similarity studies, technology development, and non-routine investigations.
Conduct complex data analysis and interpret results.
Troubleshoot analytical and laboratory issues.
Generate technical reports and presentations.
Develop acceptance criteria to support process development and comparability/similarity studies.
Collaborate with scientists across multidisciplinary and cross-functional teams.
Adapt to changing priorities in a fast-paced environment.