Senior Scientist in Biologics Analytical Development - Remote

Overview

The Analytical Operations department at Gilead is seeking a highly motivated Senior Scientist to lead the impurities development team, focusing on the development and testing of various assays and ensuring compliance with regulatory expectations.

In Short

• Lead a team of scientists focused on impurities and compendial method development.
• Drive continuous improvement of process impurity strategies.
• Support design and execution of control strategy development.
• Act as analytical development lead for late-phase programs.
• Collaborate with cross-functional teams to ensure timely delivery of projects.
• Mentor and guide team members in their roles.
• Ensure compliance with FDA and ICH guidelines.
• Draft regulatory documentation for submissions.
• Recruit and develop talent for the team.
• Foster an inclusive work environment.

Requirements

• 8+ years with BS, 6+ years with MS, or 2+ years with PhD/PharmD.
• Significant expertise in impurity method development.
• Experience with regulatory expectations and quality control.
• Strong leadership and collaboration skills.
• Ability to mentor and develop high-performing teams.
• Proven track record in drafting regulatory documentation.
• Strong business acumen and program management skills.
• Ability to set clear goals and prioritize projects.
• Experience with FDA and ICH guidelines.
• Knowledge of diverse team management.

Benefits

• Competitive salary range based on experience and location.
• Discretionary annual bonus and stock-based long-term incentives.
• Paid time off and comprehensive benefits package.
• Company-sponsored medical, dental, vision, and life insurance plans.
• Inclusive work environment fostering diversity.
• Opportunities for career development and growth.