Principal Scientist, CMC Science page is loaded## Principal Scientist, CMC Sciencelocations: EMEA, CH, Kanton Bern, Bern, CSL Behring: APAC, AU, Broadmeadows, CSL Behringtime type: Full timeposted on: Posted Todayjob requisition id: R- 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 managem...