Global MSAT Drug Product Senior Process Steward

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionPTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network.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 team is organized by product-focused Large Molecule and Small Molecule (DS & DP), Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams and operates in cross-functional squads and circles.The Drug Product Senior Process Steward , reporting to the Process Steward Group Lead DP, is the first-line connector between PTT global MSAT and our internal and external manufacturing sites. In this role you are responsible for enabling successful process industrialization by supporting during TRs, ERs, PPQ and launch phase, driving systematic process improvements according to product and portfolio needs, owning second source transfers and providing hands-on second-level commercial product support in case of investigations, CAPAs and troubleshooting in close partnership with local MSAT functions and PTT`s Product Stewards and Product Technical Leads.The OpportunityThis is a highly specialized and execution-obsessed process expert role that provides technical support across the site network on both product-specific and multi-product needs.Support Product Technical Leads and Product Stewards to ensure process industrialization (e.g., facility fit and manufacturability, PPQ support as needed, etc.), coordinate and execute process gap assessments, integrating identified risks into the risk log and developing mitigation strategiesDrive systematic process and continuous technical product health and supply improvements based on insights, including second supply and change source strategiesExecute validated state support activities, such as WCB shipment, sample coordination for additional studies, and non-routine sampling planning, and respond to evolving conditions to ensure compliance (e.g., VICs, RCAs, etc.)Provide technical expertise to technical runs and engineering runs, internally and externallyProvide hands-on second-level support (commercial product support) in the case of investigations, CAPAs and troubleshoot in close partnership with the internal and external manufacturing networkLead non-product specific RCAs and investigations on behalf of the internal manufacturing network and provide process-related mitigation of complaints and deployment of CAPAs across multiple sites or productsClosely collaborate with global and site functions (sometimes external) and leadership, including other gMSAT and PTT teams, particularly close partnership with E2E Product Technical Leads and DS or DP Technical Leads, while also serving as a digital enabler translating business needs to digital strategy and digital product development teamsWho you areWe are looking for a collaborative, technically-skilled leader with substantial experience in biopharmaceutical process development or manufacturing operations.Experience & Education: You have a B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline with 7+ years of relevant industrial experience in platform specific technical process development, process engineering or manufacturing operations (e.g. DS Bio, DP SM, etc.), PhD can be of advantageCollaborative, matrix team leadership experience and decision-making skillsDemonstrated experience in process engineering, technical process development, process validation or technology transfer, with pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing, with regulatory submission and health authority requirements, and with platform specific technology, processes and equipmentAdvanced level of verbal and written communication skills (e.g., ability to define and articulate team deliverables) incl. towards senior leadership