Process Development Sr Scientist - Thousand Oaks CA

ATTENTION MILITARY AFFILIATED JOB SEEKERS:
Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers.

Let’s do this. Let’s change the world. In this vital role you will 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. This role will provide analytical leadership for pre‑pivotal programs and apply advanced analytical techniques to characterize novel modalities in development.

Serves effectively as the Attribute Sciences representative on cross‑functional project teams and collaborates effectively with scientists across multidisciplinary teams.

Designs experiments to build a fundamental understanding of therapeutic protein attributes and stability characteristics.

Applies 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.

Evaluates analytical method performance and reliability, including the impact of proposed method changes.

Demonstrates deep understanding of product quality attributes, analytical approaches used to measure them, and strategies to ensure appropriate control.

Supports drug substance and drug product process development, protein characterization, analytical data generation for regulatory submissions, and technology transfer activities.

Authors regulatory documents and applies understanding of regulatory expectations for analytical methods, control strategies, stability strategies, and comparability.

Stays current in the field and evaluates emerging analytical technologies.

Auto req  

Minimum

Education Required:

High School/GED

Job Category:
Management

Basic Qualifications

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

• 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.

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a total rewards plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans…