Process Development Senior Scientist – Analytical Development - Remote

Overview

The Process Development Senior Scientist will play a vital role in the Pivotal Attribute Sciences Department at Amgen, focusing on late phase analytical development, method validation, and ensuring the success of drug products through pivotal clinical phases.

In Short

• Join a leading biotech company dedicated to serving patients.
• Collaborate with a team of scientists in analytical development.
• Define analytical control strategies for clinical programs.
• Develop and optimize analytical methods for drug testing.
• Provide analytical data for drug substance and product development.
• Manage activities at contract manufacturing and testing sites.
• Lead method transfers to external labs.
• Author technical reports and regulatory documents.
• Support cross-functional teams and provide leadership.
• Work in a collaborative and innovative environment.

Requirements

• Bachelor’s degree with 5 years, or Master’s with 3 years, or PhD in relevant fields.
• 2+ years of post-PhD experience in the pharma or biotech industry.
• Strong understanding of small molecule analysis and structure elucidation.
• Experience in liquid chromatography and mass spectrometry.
• Familiarity with USP monographs and ICH/FDA guidance.
• Solid understanding of GLP and GMP requirements.
• Strong communication and technical writing skills.
• Able to manage deliverables and timelines in cross-functional teams.
• Attention to detail in authoring methods and regulatory documents.
• Ability to work across various geographic locations.

Benefits

• Comprehensive employee benefits package.
• Retirement and Savings Plan with generous contributions.
• Group medical, dental, and vision coverage.
• Flexible spending accounts.
• Annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote options.
• Career development opportunities.
• Inclusive work environment focused on diversity.