Principal Scientist, CMC Science

The Principle Scientist, CMC Science is responsible for supporting and executing Chemistry, Manufacturing, and Controls (CMC) strategies for pharmaceutical and/or biologic products across clinical development and early commercialization. This role ensures that drug substance and drug product development activities meet regulatory, quality, and business objectives.​

This role works cross-functionally to drive CMC deliverables, manage external partners, and support global regulatory submissions.

Key Responsibilities

CMC Strategy & Execution

• Contribute to the development and implementation of phase-appropriate CMC strategies​
• Support CMC activities for assigned programs from early development through late-stage clinical development
• Identify risks and develop mitigation strategies to ensure timelines and quality standards are met

Process & Analytical Development

• Support drug substance and drug product development activities
• Support analytical method development, validation, and specification setting
• Support process characterization, validation, and lifecycle management

Manufacturing & Tech Transfer

• Manage relationships with CDMOs and manufacturing partners
• Support technology transfer and scale-up activities
• Ensure compliance with GMP requirements

Regulatory Support

• Author, review, and contribute to CMC sections of regulatory submissions (IND, CTA, NDA, BLA)
• Support interactions with global regulatory authorities, including the U.S. Food and Drug Administration and the European Medicines Agency
• Address regulatory questions and inspection readiness activities

Cross-Functional Collaboration

• Partner with Regulatory Affairs, Quality, Supply Chain, and Technical Operations teams
• Provide technical expertise to management team
• Support budget planning and timeline management for CMC activities

Your Profile

• PhD, MSc, or equivalent degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or related scientific discipline.

• Typically 8-10 years of experience in pharmaceutical or biotechnology development.​
• Demonstrated experience in CMC development and regulatory submissions.​
• Experience managing external manufacturing partners preferred
• Strong scientific and technical expertise in CMC disciplines​
• Knowledge of global regulatory guidelines (ICH, GMP)​
• Project leadership and stakeholder management​
• Risk assessment and problem-solving skills​
• Excellent communication and organizational skills

Are you interested? We are looking forward to receiving your online application

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CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring .

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