Vaccine Technology Transfer Specialist
Take on a key role in technology transfer and support seamless vaccine manufacturing process introduction, ensuring compliance, efficiency, and high-quality production.
Responsibilities:
* Technology Transfer & Process Scale-Up: Lead and coordinate activities such as process validation, PPQ batch manufacture, regulatory submissions, and audit readiness.
* Technical Expertise & Compliance: Ensure all processes meet the highest standards of quality, safety, and compliance with regulatory requirements.
* Continuous Improvement & Innovation: Stay up to date with advancements in vaccine and biopharmaceutical technologies, identifying opportunities to enhance manufacturing processes through innovation and Lean principles.
* Problem-Solving & Performance Optimization: Use data-driven decision-making and root cause analysis to troubleshoot issues, streamline operations, and improve efficiency.
* Collaboration & Stakeholder Management: Work cross-functionally with technical teams, quality assurance, regulatory affairs, and external partners to ensure successful technology transfer and ongoing process improvements.
* Documentation & Regulatory Support: Contribute to the preparation and approval of technical documents, change controls, deviation reports, and quality notifications.
Requirements:
* Education: Degree or Master's in Science or Engineering (preferably Biotechnology).
* Experience: 4+ years in biopharmaceutical or vaccine manufacturing, with experience in process scale-up, validation, or technical projects.
* Technical Skills: Strong understanding of biopharmaceutical processes, regulatory compliance (FDA/HPRA), and technical problem-solving.
* Project Management: Experience in managing technical projects, with the ability to coordinate multiple stakeholders and deliver results on time.
* Lean & Continuous Improvement: Exposure to Lean Six Sigma or other process improvement methodologies is a plus.
* Software & Systems: Proficiency in data analysis tools and Microsoft Office (Excel, Word, PowerPoint).