Technical Transfer Specialist - Manufacturing Operations
The Technical Transfer Specialist supports the introduction of new assays, reagents, and bulk materials for tissue diagnostics into Roche's manufacturing processes. This role ensures the seamless integration of new products from Development into Operations, focusing on manufacturability, quality, cost, and schedule. You will leverage technical knowledge, project management skills, and lean manufacturing principles to support efficient, scalable, and compliant manufacturing practices.
Required qualifications include a Bachelor's or Master's degree in a Life Sciences or Engineering discipline, minimum of 1 year of relevant work experience, preferably within the pharmaceutical, biotechnology, or medical devices industry, experience operating in a GMP/regulated environment, basic knowledge of Lean principles, excellent stakeholder management, communication, and project coordination skills, proven ability to follow standard operating procedures, operational procedures, and quality protocols, ensuring compliance and data integrity, strong teamwork ethic, and exceptional interpersonal skills.
Key responsibilities include executing product design transfer tasks, coordinating process transfers, collaborating cross-functionally, documenting and integrating manufacturing requirements, utilizing project management methodologies, supporting process validation readiness, participating in training and mentorship, ensuring processes are conducted safely, assisting in audit readiness, keeping updated with relevant regulations, learning and applying basic Lean principles, using statistical tools to analyze process data, developing and maintaining standardized procedures, and possessing foundational knowledge in applying scientific methods and principles to process transfer tasks.