Global MSAT Senior DP Product Steward

About the role

As part of Pharma Technical Operations (PT), Pharma Technical Technology (PTT) plays a key role in leading a seamless industrialization and thorough technical product management. Within PTT, Roche's global Manufacturing Science and Technology (gMSAT) department is the process and product owner for commercial products, including internal and external drug substance and drug product networks, implementation of new technologies, network standardization, and mitigation of technical risks.

The Senior Large Molecule DP Product Steward is responsible for driving seamless technical industrialization and sustaining and improving the technical health of commercial products, starting from manufacturability decision through process performance qualification, supply maturity and optimization, and ultimately divestment. This role is accountable for delivering on the product’s technical strategic roadmap, which includes investigating and mitigating technical risks, implementing improvements, and aligning strategies with broader network objectives.

Responsibilities

• Lead and execute technical industrialization and technical product health activities to ensure a successful launch and maintain robustness through the product lifecycle, from launch to divestment.
• Identify, define, and deliver DP-related technical industrialization strategies and improvements to support successful launch and ongoing product validation, robustness, cost-effectiveness, and compliance.
• Drive technical product health with accountability for the strategic roadmap, risk management, technical changes/issues, manufacturability, and performance management.
• Serve as the primary product technical owner for site leadership and quality functions when investigating product or process issues across the commercial lifecycle.
• Represent the product in key technical governance forums and senior stakeholder interactions.

Requirements

• B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology, etc.), with at least 7+ years of relevant industrial experience in platform-specific process development or supporting platform-specific manufacturing operations (e.g., DS Bio, DP SM, etc.). A PhD is advantageous.
• Proven record in Drug Product manufacturing and product and technology industrialization as well as process development in the field of biological molecules.
• Significant cross-functional matrix leadership experience.
• Demonstrated experience with technology transfer and/or process validation.
• Strong understanding of regulatory submission and health authority requirements as well as patient needs/patient-centricity as key elements of design and delivery.

Less than 10% travel required. Relocation benefits are not available for this posting.

Pay

The expected salary range for this position based on the primary location of California is $131,500 to $244,300. 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.

Benefits

This position qualifies for the benefits detailed at the provided link.