Global MSAT DS Principal Product 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) in Pharma Technical Operations (PT) leads industrialization and technical product management, enhancing robustness, efficiency, and reliability.

Roche's global Manufacturing Science and Technology (gMSAT) handles commercial products, new technologies, standardization, and risk mitigation.

The Principal Product Steward ensures seamless industrialization and product health from manufacturability to divestment. They lead technical strategies, improvements, and risk management, ensuring product quality and reliability, and represent products in key forums.

• Develop, lead, and execute technical industrialization and product health activities to ensure successful launches and lifecycle robustness from launch to divestment. Strategically manage post-launch ramp-up for sustainable scale-up and long-term product success
• Coordinate and own tech transfer process gap assessments, integrating identified risks into the risk log and developing mitigation strategies. Identify, manage, and close technical risks through Technical Product Teams risk logs, and escalate significant issues as needed
• Develop and implement master plans for DS and DP, ensuring alignment with technical roadmaps and continuous improvement opportunities. Drive start-to-finish ownership of control processes for internal commercial sites and external CMO sites
• Coordinate proactively with Quality to meet quality milestones across the commercial lifecycle. Manage and report on functional product health metrics and prepare for Product Quality Management Reviews (PQMR)
• Lead root cause analysis for DS or DP-related issues, implement mitigations, and represent technical input in governance forums. Review complaints reports and assess mitigation and corrective activities (CAPAs)
• Oversee and own relevant platforms and tools to ensure alignment across teams and projects. Ensure SHE checkpoints are conducted regularly and solutions are implemented to enhance safety and sustainability
• Lead a matrix team of senior experts and network teams for resilient or established products. Provide Global MSAT representation in governance committees, interface with other gMSAT and PTT teams, and define and deliver team outcomes in alignment with strategic goals. Manage staffing, resources, and project prioritization to ensure successful outcomes

• Requires a B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology, etc.) with at least 10+ years of relevant industrial experience in product or process development or manufacturing operations. A PhD is advantageous
• Proven record in Drug Substance or Drug Product manufacturing, product and technology industrialization, and process development in biological molecules. Recognized authority in the field with in-depth knowledge of platform-specific technology, processes, equipment, regulatory submission, and health authority requirements
• Significant cross-functional matrix leadership experience with advanced VACC leadership skills. Excellent strategic planning and decision-making skills, along with business and financial acumen, influencing, collaboration, and networking abilities
• Demonstrated experience in pharmaceutical quality systems, industry-wide guidelines, technology transfer, and process validation. Strong understanding and application of these aspects in platform-specific process development and manufacturing
• Advanced communication skills to define and articulate team deliverables to senior leadership. Deep understanding of patient needs and incorporating patient-centricity into design and delivery. Willingness to travel less than 10%

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be an outstanding opportunity to craft the future of Roche.

Relocation benefits are available for this posting.

The expected salary range for this position based on the primary location of California is $159,000 to $295,200 annually.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

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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.

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