New

Global MSAT DS Principle Process Steward

Genentech
United States, California, Oceanside
1 Antibody Way (Show on map)
Apr 22, 2025
The Position 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. The Opportunity 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. 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 Experience & Education: You have a B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline with at least 10+ years of relevant industrial experience in platform specific technical process development, process engineering or manufacturing operations (e.g. DS Bio, DP SM, etc.), PhD can be of advantage Leadership: collected significant matrix leadership experience over the last years, collaborative, team leadership and decision-making skills Technical Expertise: Demonstrated experience in process engineering, technical process development, process validation or technology transfer, with pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing, with regulatory submission and health authority requirements, and with platform specific technology, processes and equipment Outstanding Communicator: Advanced level of written and verbal communication skills (e.g., ability to define and articulate team deliverables) incl. towards senior leadership <10% travel required Relocation benefits are available for this posting The expected salary range for this position based on the primary location of California is $138,300-$256,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.