Process Development Associate Scientist

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. In this role, you will be responsible for analytical and biochemical characterization activities for pre-clinical biotherapeutic protein development. This includes assay development for biochemical characterization with an emphasis on mass spectrometry and high-pressure liquid chromatography (HPLC), planning and execution of experiments in support of pre-clinical candidate selection, process development, and lead molecule characterization.

You will perform biochemical characterization of candidate drug products using peptide mapping and intact protein LC-MS analysis, characterize candidate molecules to support protein primary structure, and analyze drug candidate chemical and post-translational modifications (quality attributes). Automation platforms and liquid handling systems are used in this work. You will also generate technical documents and presentations, manage analytical laboratory operations, schedule repairs, and perform method suitability testing of equipment.

This position supports the generation of regulatory submissions, patents, and publications, and involves exploring and evaluating emerging technologies relevant to MS-based characterization of therapeutic proteins.

Responsibilities

• Develop assays for biochemical characterization using mass spectrometry and HPLC.
• Plan and execute experiments to support pre-clinical candidate selection and process development.
• Perform biochemical characterization of candidate drug products, including peptide mapping and intact protein LC-MS analysis.
• Characterize candidate molecules to confirm protein primary structure and analyze chemical/post-translational modifications (quality attributes).
• Utilize automation platforms and liquid handling systems in laboratory work.
• Generate technical documents and presentations for internal and external use.
• Manage analytical laboratory operations, including scheduling repairs and performing method suitability testing of equipment.
• Provide scientific results to support regulatory submissions, patents, and publications.
• Explore and evaluate emerging technologies for MS-based characterization of therapeutic proteins.

Requirements

• Master’s degree and 1 year of relevant industrial experience OR Bachelor’s degree and 3 years of relevant industrial experience.

Qualifications

• Master’s or Bachelor’s degree in analytical chemistry, chemistry, biochemistry, pharmaceutical sciences, physical sciences, chemical engineering, or biological sciences.
• Expertise with HPLC and mass spectrometry.
• Experience with statistical software, including Excel or similar tools.
• Experience within analytical testing or the biotech industry, including data analyses, statistical analysis in support of process development, and comparability studies.
• Strong problem-solving skills requiring the application of scientific theory.
• Excellent laboratory work skills for executing scientific experiments and interpreting results.
• Strong written and oral communication skills for documenting, presenting, and discussing scientific results in a fast-paced, multi-disciplinary environment.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on relevant skills, experience, and qualifications.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program (or sales-based incentive plan for field sales representatives).
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.