About the role
- The Position As part of Pharma Technical Operations (PT), Pharma Technical Technology (PTT) plays a key role in leading a seamless industrialization and thorough technical product management. Within PTT, Roche’s global Manufacturing Science and Technology (gMSAT) department is the process and product owner for our commercial products, including our internal and external drug substance and drug product network, implementation of new technologies, network standardization, and mitigation of technical risks. The Opportunity The Senior Large Molecule DP Product Steward is responsible for driving seamless technical industrialization and sustaining and improving the technical health of commercial products, starting from manufacturability decision through process performance qualification (PPQ), supply maturity and optimization, and ultimately divestment. Your main responsibilities cover Technical Industrialization (Develop Technical Strategic Roadmap), Product Technical Health Management (Own & Mitigate Technical Risks) and Technical Leadership
- Provide technical oversight of commercial DPs from launch to divestment to consistently deliver quality products to patients
- Identify, define, and deliver DP-related technical industrialization strategies and technical improvements to ensure successful launch as well as that the product remains validated, robust, cost-effective, and compliant
- Drive the technical product health including accountability for strategic roadmap, risk management, technical changes/issues, manufacturability and performance management Serve as a primary product technical owner for site leadership and quality functions when investigating product or process issues across the commercial lifecycle Represent the product in key technical governance forums and senior stakeholder interactions Who you are The ideal candidate is a recognized authority in the field, bringing deep scientific expertise, extensive industrial experience, and exceptional leadership capabilities. B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc. ), with at least 7+ years of relevant industrial experience in platform specific process development or in supporting platform specific manufacturing operations (e.g. DS Bio, DP SM etc.), PhD is of advantage
- Proven record in Drug Product manufacturing and product and technology industrialization as well as process development in the field of biological molecules. Significant cross-functional matrix leadership experience Demonstrated experience with technology transfer and/or with process validation
- Strong understanding of regulatory submission and health authority requirements as well as patient needs / patient-centricity as key elements of design and delivery Ready for the next step? We look forward to hearing from you.