Global MSAT Senior Product & Process Steward at F. Hoffmann-La Roche Ltd - Poland

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

03 Jun, 26

Salary

0.0

Posted On

05 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Health, Industrialization, Synthetic Molecule Manufacturing, Matrix Leadership, Technology Transfer, Process Development, Validation Oversight, Regulatory Submissions, Risk Mitigation, Continuous Improvement, Data-Driven Decisions, CMC Leadership, Strategic Vision, Stakeholder Alignment, Process Optimization, Troubleshooting

Industry

Biotechnology Research

Description

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 Position 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 substances. 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. As 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. You operate at the intersection of science, strategy, and operations - translating complex technical challenges into sustainable, forward-looking manufacturing solutions. Your work directly impacts product availability, regulatory confidence, and business success - ultimately benefiting patients around the world. The Opportunity 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 which includes the following responsibilities: Own the Drug Substance Lifecycle: from pivotal development milestones through PPQ, commercialization, and eventual divestment, you ensure robust, efficient, reliable, and compliant processes. 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). Provide technical oversight during start-up and routine operations. Validation Oversight: oversee validation activities at the CDMO and ensure validation strategies meet regulatory expectations. 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. Who You Are 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 are energized by accountability, comfortable making high-impact decisions, and motivated by delivering sustainable manufacturing solutions at scale. You bring: An advanced degree in Chemistry or a related discipline (PhD preferred). 7+ years of industry experience in drug substance development or commercial manufacturing. Proven expertise in process development and validation, technology transfer, and synthetic molecule manufacturing. A proactive, structured mindset with a strong focus on quality, compliance, and reliability. The ability to inspire trust, align diverse stakeholders, and translate complexity into clarity. Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity! Who we are 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.

Responsibilities

The Senior Product & Process Steward owns the entire drug substance lifecycle, ensuring robust, efficient, and compliant processes from development through commercialization and divestment. This role involves driving technical industrialization strategies, leading technology transfers to CDMOs, and providing technical oversight for manufacturing operations and validation activities.