Global MSAT Drug Product Senior Process Steward

PTT (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 Opportunity

This 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 strategies

• Drive systematic process and continuous technical product health and supply improvements based on insights, including second supply and change source strategies

• Execute 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 externally

• Provide 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 network

• Lead 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 products

• Closely 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 teams.

Who you are

We 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 advantage

• Collaborative, matrix team leadership experience and decision-making skills

• Demonstrated 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 equipment

• Advanced level of verbal and written communication skills (e.g., ability to define and articulate team deliverables) incl. towards senior leadership

• <10% travel required  

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!