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

Moscow, Moscow, Russia -

Full Time

Start Date

Immediate

Expiry Date

01 Apr, 26

Salary

0.0

Posted On

02 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Process Engineering, Manufacturing Operations, Technical Process Development, Process Validation, Technology Transfer, Pharmaceutical Quality Systems, Regulatory Submission, Health Authority Requirements, E. Coli Processes, CHO Processes, Communication Skills, Collaboration, Risk Management, Troubleshooting, Continuous Improvement

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 Global MSAT DS Senior Process Steward A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. Pharma Technical Technology (PTT) within Pharma Technical Operations (PT) enhances industrialization and product management by integrating SHE, maintenance, performance optimization, and scalable processes for improved robustness, efficiency, and reliability. Roche’s global Manufacturing Science and Technology (gMSAT) manages commercial products, new technologies, standardization, and risk mitigation, organized into Large and Small Molecule (DS & DP) teams. The Process Steward Large Molecule DS connects global MSAT with manufacturing sites, supporting process industrialization, driving improvements, managing second-source transfers, and providing second-level support for product issues. They represent network technological needs in governance forums and stakeholder interactions. The Opportunity Support Product Technical Leads and Product Stewards in ensuring process industrialization, coordinate and execute process gap assessments, integrate identified risks into the risk log, and develop mitigation strategies. Drive systematic process and continuous technical product health and supply improvements based on insights, including second source and change strategies Execute validated state support activities and respond to evolving conditions to ensure compliance (e.g., VICs, RCAs) Provide technical expertise for technical and engineering runs and hands-on second-level support for investigations, CAPAs, and troubleshooting in partnership with the internal and external manufacturing network. Lead non-product specific RCAs and investigations Leverage the pilot plant team for real-life and scaled experimentation to support process-related projects, including validation studies and process transfer to manufacturing sites Ensure the implementation of network initiatives that are aligned and prioritized with manufacturing site plans, and incorporate portfolio-wide impacting aspects like direct material changes and Health Authority requirements Collaborate closely with global and site functions, leadership, and other gMSAT and PTT teams. Serve as a digital enabler, translating business needs to digital strategy and digital product development teams and driving technical sustainability improvements for product, process, and technology Who you are B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline with 7+ years of relevant industrial experience in process development, process engineering, or manufacturing operations. A PhD is advantageous Experience in collaborative, matrix team leadership and decision-making Demonstrated experience in process engineering, technical process development, process validation, or technology transfer (E. coli & CHO processes). Familiarity with pharmaceutical quality systems, industry guidelines, regulatory submission, health authority requirements, and platform-specific technology, processes, and equipment Advanced verbal and written communication skills, with the ability to define and articulate team deliverables effectively, including towards senior leadership Willingness to travel less than 10% as required. 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The role involves supporting Product Technical Leads and Product Stewards in process industrialization and managing second-source transfers. Additionally, it includes providing technical expertise for investigations and ensuring compliance with evolving conditions.