Senior Scientist II, CMC Sciences Biologics Development and Launch - Remote

Overview

The Senior Scientist II role focuses on supporting regulatory approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls (CMC) filing content and leading cross-functional CMC teams throughout development phases.

In Short

• Author regulatory documents including INDs and BLAs.
• Collaborate with subject matter experts to ensure accurate technical information.
• Lead CMC teams in developing control strategies.
• Align with key stakeholders and escalate issues as needed.
• Contribute to program acceleration and efficiency initiatives.

Requirements

• BS in Biology, Biochemistry, Engineering, or related field with relevant experience.
• Knowledge of biologics manufacturing processes.
• Understanding of Good Documentation Practices (GDP).
• Familiarity with scientific and regulatory requirements for biopharmaceuticals.
• Proficiency in Microsoft Word and Excel.

Benefits

• Comprehensive benefits package including paid time off.
• Medical, dental, and vision insurance.
• Participation in short-term and long-term incentive programs.