global MSAT Senior DP Product Steward

Roche • Hillsboro, OR

1d • Onsite

About The Position

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 our commercial products, including our internal and external drug substance and drug product network, implementation of new technologies, network standardization, and mitigation of technical risks. The Opportunity 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 (PPQ), supply maturity and optimization, and ultimately divestment.

Requirements

• B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc. )
• at least 7+ years of relevant industrial experience in platform specific process development or in supporting platform specific manufacturing operations (e.g. DS Bio, DP SM etc.)
• 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 with 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

Nice To Haves

• PhD is of advantage

Responsibilities

• Develop Technical Strategic Roadmap
• Own & Mitigate Technical Risks
• Provide technical oversight of commercial DPs from launch to divestment to consistently deliver quality products to patients
• Identify, define, and deliver DP-related technical industrialization strategies and technical improvements to ensure successful launch as well as that the product remains validated, robust, cost-effective, and compliant
• Drive the technical product health including accountability for strategic roadmap, risk management, technical changes/issues, manufacturability and performance management
• Serve as a 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior