Principal Scientist, Biologics

📋 Description

• Lead process development activities across analytical sciences, purification, formulation, and
• Review and approve manufacturing documentation, including standard operating procedures, batch
• Ensure compliance with GMP, quality management systems, and regulatory expectations through
• Author and review source documents and CMC content for regulatory submissions, including IND, NDA
• Apply scientific judgment to complex regulatory and technical topics, including comparability
• Lead collaborations with internal sites and external CMC partners, assessing technical

🎯 Requirements

• A degree in science or engineering with relevant experience: Bachelor's degree: 11 years, Master's
• At least 5 years of experience in GMP environments, quality management systems, and CMC compliance
• Strong technical knowledge in one or more biologics development areas such as analytical sciences
• Demonstrated understanding and application of project management principles, including planning
• Experience supporting process development, technology transfer, analytical method transfer
• Ability to work effectively in cross-functional and virtual teams, manage competing priorities, and

🎁 Benefits

• Competitive salary
• Annual performance-based bonus
• Equity-based incentive program
• Generous vacation allowance
• Paid wellness days
• Learning and professional development support