Principal Scientist, Tech Ops (Tech Transfer and Outsourcing) — CSL Behring

Role overview

• Lead and oversee technology transfer activities for processes and/or QC analytical methods, including transfer between development, manufacturing, and external partner laboratories.
• Define and execute transfer strategies, protocols, acceptance criteria, and readiness assessments to ensure successful implementation at receiving sites.
• Serve as the primary technical point of contact for external partners, including CDMOs and contract laboratories, ensuring alignment on technical expectations, timelines, and quality standards.
• Provide scientific oversight of outsourced activities, including issue resolution, deviation investigations and performance monitoring.
• Support preparation, review, and defense of CMC-related regulatory documentation associated with tech transfer, outsourcing, and lifecycle changes.
• Provide scientific input to regulatory interactions, including responses to health authority questions related to transferred technologies.
• Support post-approval lifecycle activities, including site additions, method updates, and continuous improvement initiatives.
• Collaborate effectively with cross-functional stakeholders (e.g., Development, Manufacturing, Quality, Regulatory Affairs, etc).
• Researches and develops new medicines for unmet medical needs through innovative medical science from inception, through clinical trials to commercialization.
• Assesses, monitors and ensures products meet clinical safety standards.
• Conducts sophisticated analysis, manages research information systems and technical documentation.
• May be involved in providing para-professional laboratory support for product testing after collection.
• Provide high level scientific expertise and guidance in specialist technical areas of research and product development related activities.
• Implements technical capabilities with and provides relevant technical guidance to other team members in order to achieve specified research project objectives within defined time parameters.
• Contributes to the planning, performance, evaluation and reporting of scientific experiments at the highest levels of scientific integrity
• Contributes to training of staff in relevant research and development technology platform

Responsabilità principali & Accountabilità

• Providing leadership for projects and workstreams in a matrix organization
• Recognized subject matter expert in job area typically obtained through advanced education and work experience
• Manages large projects or processes with limited oversight from manager
• Coaches, trains, reviews, and delegates work to lower level professionals
• Problems faced are difficult and often complex, requiring analysis of issues and consideration of other job areas

• Postgraduate degree (preferably MSc or PhD) and / or extensive experience in relevant discipline.
• Minimum of 5 years' relevant industry experience and / or equivalent experience in a relevant academic environment.
• Track record of scientific achievement in relevant Life Sciences discipline.
• Experience working in cross-functional, multicultural and international teams.
• Excellent communication skills (English language).