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Die Position
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 commercial products, encompassing internal and external drug substance and drug product sites, new technology implementation, network standardization, and mitigation of technical risks. The gMSAT team is structured with product-focused Large Molecule and Synthetic Molecule (Drug Substance & Drug Product), Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams, operating in cross-functional squads and circles.
The Opportunity
The Principal Product & Process Steward (Synthetic Molecules) 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 are:
Identify, define, and deliver DS (Drug Substance) or DP (Drug Product)-related technical industrialization strategies and technical improvements to ensure successful launch as well as that the product remains validated, robust, cost-effective, and compliant, while also acting as the deep subject matter expert (SME) for the underlying manufacturing process platform.
Act as a key connector between gMSAT and the internal/external manufacturing sites, serving as a highly specialized and execution-focused subject matter expert (SME) for the process platform
Deliver on the product's technical strategic roadmap across the commercial lifecycle, as defined by a Product Technical Lead, which includes investigating and mitigating technical investigations and risks, implementing improvements, and aligning strategies with broader network objectives.
Serve as a primary product technical owner for site leadership and quality functions when investigating product or process issues across the commercial lifecycle. This includes providing hands-on, second-level technical support for complex investigations, CAPAs, and troubleshooting in close partnership with local MSAT functions and the internal/external manufacturing network.
Represent the product in key technical governance forums and senior stakeholder interactions
For marketed synthetic molecule products where no Product Technical Lead is assigned, take on an extended role as End-to-End Product Steward, leading the Product Technical Team and fully representing and delivering on the technical agenda. In these cases, you hold primary accountability for ensuring functional (e.g. DS, DP, Device & Packaging) product quality, reliability, and the execution of long-term strategic goals and operational targets through the effective direction and management of a matrixed team and financial resources.
Take on this matrix leadership accountability for multiple synthetic molecule products
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