Principal Scientist Tech Ops (CMC Science)

Description du poste

Join CSL Behring as a Principal Scientist in Bern, focusing on CMC strategies. This role offers a dynamic work environment with growth opportunities. Tasks Develop and implement phase-appropriate CMC strategies. Support drug substance and product development activities. Manage relationships with external manufacturing partners. Skills PhD or MSc in a related field with 8-10 years experience. Strong scientific expertise in CMC disciplines required. Excellent communication and organizational skills essential. About the job We are currently looking for a Principal Scientist Tech Ops (CMC Science) to join our global team in Bern. In this position you will be 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 Was wir bieten Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, was wir bei CSL bieten . Über CSL Behring 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 . CSL soll so vielfältig sein wie die Welt, in der wir leben Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL. Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!