Process Development Sr. Scientist

About the role

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Responsibilities

• Support Amgen’s diverse early-stage therapeutic portfolio by characterizing process and product properties of large-molecule drug candidates and assessing quality attributes of protein therapeutics across multiple pipeline areas.
• Provide analytical leadership for pre-pivotal programs and apply advanced analytical techniques to characterize novel modalities in development.
• Serve effectively as the Attribute Sciences representative on cross-functional project teams and collaborate effectively with scientists across multidisciplinary teams.
• Designs experiments to build a fundamental understanding of therapeutic protein attributes and stability characteristics.
• Apply advanced technical expertise in analytical methods to characterize protein therapeutics, including CE, SEC, IEX, RP, HILIC, and mass spectrometry, with strong understanding of the theoretical and practical aspects of stability-indicating assays, including design, performance, and data interpretation.
• Evaluate analytical method performance and reliability, including the impact of proposed method changes.
• Demonstrate deep understanding of product quality attributes, analytical approaches used to measure them, and strategies to ensure appropriate control.
• Support drug substance and drug product process development, protein characterization, analytical data generation for regulatory submissions, and technology transfer activities.
• Author regulatory documents and apply understanding of regulatory expectations for analytical methods, control strategies, stability strategies, and comparability.
• Stay current in the field and evaluate emerging analytical technologies.

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master’s degree and 3 years of directly related life science experience OR Bachelor’s degree and 5 years of directly related life science experience.

Preferred Qualifications

• Ph.D. in analytical chemistry, biochemistry, biophysics, or a related life science field, with 2 years of industry experience.
• Strong expertise in developing, qualifying, and troubleshooting analytical methods using HPLC/UPLC, CE, mass spectrometry, and related technologies to characterize protein therapeutics.
• Proven experience in separation sciences, protein chemistry, and/or mass spectrometry.
• Strong laboratory skills, including experimental design and execution, complex data interpretation, and timely delivery of results.
• Familiarity with common therapeutic protein quality attributes, such as fragmentation, deamidation, oxidation, and partial reduction, as well as tools used for their characterization and quantification.
• Understanding of, or experience with, GMP compliance.
• Ability to work independently to advance projects and studies within required timelines.
• Excellent written and verbal communication skills, with the ability to document, present, and discuss scientific results in a fast-paced, multidisciplinary environment.