Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
The MSAT PE Lead/Subject Matter Expert (SME) is a pivotal technical role, designed for talented individuals who bring unparalleled expertise in developing and integrating advanced biomanufacturing processes. The ideal candidate will be an influential collaborator within the team, demonstrating significant technical depth capable of addressing complex challenges and advancing Roche’s process engineering strategy. By contributing at a strategic level, the PE SME
will drive end-to-end process engineering projects across greenfield projects and routine operations, reducing time-to-market, improving efficiency, and ensuring excellence throughout the product lifecycle. Additionally, this role also encompasses responsibilities in single-use technology (SUT) implementation, identifying opportunities for continuous improvement, and ensuring that all technical documentation and knowledge transfer activities meet the highest
standards. With strong collaboration across cross-functional teams and internal and external stakeholders, this role will keep providing comprehensive operational support, driving technical innovation, and optimizing manufacturing efficiency across the board.
Engineering Project Support& Operations:
- Serve as a technical authority and strategic advisor for process engineering within the MSAT organization, driving excellence in manufacturing processes, validation, and key performance monitoring to ensure compliance with cGMP/SHE standards and Roche’s quality policies.
- Lead strategic project realization including facility design, qualification and operational efficiency improvements.
- Provide deep technical expertise in end-to-end process monitoring, troubleshooting, and optimization to maintain consistent product quality, enhance efficiency, and mitigate operational risks.
- Champion process innovation and continuous improvement by identifying opportunities to optimize critical parameters, enhance automation capabilities, and improve product yield and reliability.
- Manage complex troubleshooting efforts in production, driving root-cause analysis, risk assessment, and implementing sustainable solutions to ensure minimal disruption to operations.
SUT Strategy& Implementation:
- Provide critical support to the SUT SME for the design, qualification, and implementation of SUT systems into MSAT operations, ensuring robust integration and compliance with regulatory expectations.
- Deeply involved in SUT innovation, optimization, and risk mitigation across all phases of product lifecycle (NPI, scale-up, commercialization) to enhance operational efficiency, reduce costs, and accelerate time-to-market.
- Contribute to SUT-related activities, including extractables and leachables (E) studies, compatibility assessments, and risk mitigation to enhance operational efficiency and reduce time-to-market.
Influential Leadership& Global Interaction:
- Demonstrates strong creative leadership mindset and skills with a proven ability to cultivate a forward-thinking outlook and effectively eliminate barriers to progress.
- Collaborate with cross-functional teams (RD, QA, Engineering, Supply Chain) to optimize process transfers, scale-up operations, and address production bottlenecks.
- Facilitate robust interaction and collaboration with global team members, internal stakeholders, and external partners to support the PE implementation and process optimization.
- Provide timely updates, promote effective knowledge sharing, and establish efficient coordination mechanisms to drive alignment on key initiatives and project milestones.
Qualification and Experience
- Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above
- At least 5 years of experience in Process Engineering, with a minimum of 8 years MSAT/Technical or operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
- Prior experience in people management is advantageous
- Proven expertise in strategic project of Aseptic Filling facility, including design, commissioning& qualification
- Hands-on experience in new facility startup readiness and operational ramp-up processes
- Comprehensive knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry
- Ability to think strategically, translate high-level strategies into actionable plans, and embrace agile methodologies to foster adaptability and effectiveness
- Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
