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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.
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.
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!
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.