Global MSAT Senior Product & Process Steward
Listed on 2026-03-13
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Manufacturing / Production
Manufacturing Engineer, Quality Engineering
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Shape the Future of Manufacturing Excellence!
Global MSAT, Engineering and Sustainability (PTT) serves as the technical backbone of Roche’s commercial portfolio. We ensure that every product reaching patients is manufactured with excellence, reliability, and uncompromising quality.
We are seeking a Senior Product & Process Steward to take end-to-end ownership of the technical health and industrialization of our synthetic molecule drug products. This is more than a technical role - it is an opportunity to shape global manufacturing strategy, enable successful product launches, and safeguard supply for patients worldwide.
Your work directly impacts product availability, regulatory confidence, and business success - ultimately benefiting patients around the world.
This position offers a unique opportunity to operate at the heart of Roche’s commercial manufacturing network. You shape technical strategy, influence global decision-making, and contribute to a culture of operational excellence.
If you are driven by ownership, motivated by impact, and ready to lead technical excellence on a global scale, we look forward to exploring this opportunity with you.
The opportunityAs a matrix leader and recognized technical authority, you bridge development and commercial manufacturing across Roche’s global manufacturing network, with a primary focus on external partnerships, and you operate at the intersection of science, strategy, and operations - translating complex technical challenges into sustainable, forward-looking manufacturing solutions.
Own the Drug Product Lifecycle – From pivotal development milestones through PPQ, commercialization, and eventual divestment, you will ensure robust, efficient, reliable, and compliant processes, acting as the deep subject matter expert for parenteral synthetic molecules, particularly compounding and fill‑finish operations for oligonucleotide and peptide formulations.
Enable Seamless Launches – Drive technical industrialization strategies, including CDMO site selections, and lead successful technology transfers to our CDMO network.
Operational Support:
Support implementation of manufacturing operations at the CDMO site (e.g., equipment alignment, process optimization, troubleshooting, specifically for complex parenteral compounding and fill‑finish lines). Provide technical oversight during start‑up and routine operations.Validation Oversight:
Oversee validation activities at the CDMO and ensure validation strategies meet regulatory expectations for sterile and non‑sterile processes.Documentation – Author and review technical reports, validation documents, and regulatory submissions to enable efficient industrialization and lifecycle management.
Safeguard Supply – Anticipate and mitigate risks, securing reliable delivery of starting materials, intermediates, and drug substances.
Drive Continuous Improvement – Elevate manufacturing performance through data‑driven decisions that enhance efficiency, safety, sustainability, and compliance.
You are a seasoned CMC leader who thrives in complexity and takes pride in technical depth. You combine scientific rigor with strategic vision and excel at influencing across a global matrix organization. You bring:
An advanced degree in Pharmacy or a related discipline (PhD preferred) with 7+ years of industry experience in drug product development or commercial manufacturing of oral dosage forms and, crucially, parenteral synthetic molecules (with a specific focus on compounding and fill‑finish operations for oligonucleotide and peptide formulations).
Proven expertise in process…
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