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

Overview

The Senior Scientist will support the regulatory approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls (CMC) filing content and leading cross-functional CMC teams throughout Phase 1, Phase 2, and Phase 3 development.

In Short

• Author sections of regulatory documents, including INDs and BLAs.
• Partner with subject matter experts in various process development functions.
• Lead CMC teams in developing control strategies.
• Drive alignment with key business stakeholders.
• Contribute to program acceleration and efficiency initiatives.

Requirements

• BS in Biology, Biochemistry, Engineering or related discipline with 8+ years of experience.
• Knowledge of biologics manufacturing processes.
• Knowledge of Good Documentation Practices (GDP) and technical writing.
• Understanding of scientific and regulatory requirements for biopharmaceutical products.
• High proficiency in Microsoft Word and Excel.

Benefits

• Comprehensive benefits package including paid time off.
• Medical/dental/vision insurance.
• 401(k) plan for eligible employees.
• Participation in short-term and long-term incentive programs.