Process Development Associate Scientist

Amgen•Thousand Oaks, CA

1d•$74,503 - $100,799

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. The work supports product and process characterization and regulatory submissions. Experience with 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 for process development and comparability/similarity studies. The position calls for strong scientific and analytical skills, collaboration with multidisciplinary and cross-functional teams, and flexibility in a fast-paced environment with changing priorities.

Requirements

Bachelor’s degree; or an associate’s 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 such experience.
Strong scientific and analytical skills.
Ability to work collaboratively with scientists across multidisciplinary and cross-functional teams.
Flexibility to adapt to changing priorities in a fast-paced environment.

Nice To Haves

Two or more years of experience directly related to the biophysical characterization of proteins, including hands-on experience with IR, CD, UV-visible spectroscopy, and DSC for thermal stability analysis.
Hands-on experience with HPLC systems for protein separation and characterization.
Strong laboratory and analytical skills, including routine testing; designing and executing scientific experiments; analyzing data and interpreting results; and maintaining accurate laboratory records.
Experience developing, qualifying, and/or validating analytical methods; analyzing and interpreting complex data; and establishing acceptance criteria for product comparability and similarity studies.
Demonstrated ability to collaborate effectively with scientists across multidisciplinary and cross-functional teams.
Strong technical communication skills, including preparing technical reports, scientific presentations, and documentation supporting regulatory activities.
Ability to work independently, manage multiple priorities, and adapt effectively to evolving project needs and timelines.

Responsibilities

Perform sample preparation and analytical testing.
Develop methods and characterize biologics using biophysical and spectroscopic techniques, including IR, CD, UV-visible spectroscopy, and DSC.
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 interpretation.
Troubleshoot analytical or process-related 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.