Process Development Sr Scientist - Thousand Oaks CA

Military Spouse Corporate Career Network • Thousand Oaks, CA

27d • Onsite

About The Position

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.

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

Nice To Haves

• 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.

Responsibilities

• Provide analytical leadership for pre-pivotal programs.
• Apply advanced analytical techniques to characterize novel modalities in development.
• Serve as the Attribute Sciences representative on cross-functional project teams.
• Collaborate effectively with scientists across multidisciplinary teams.
• Design 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.
• Maintain a 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.

Benefits

• A 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
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior