About The Position
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network. 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 team is organized by product-focused Large Molecule and Small Molecule (DS & DP), Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams and operates in cross-functional squads and circles. The Opportunity The Principal 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. Your main responsibilities cover Technical Industrialization (Develop Technical Strategic Roadmap), Product Technical Health Management (Own & Mitigate Technical Risks) and Technical Leadership:
Requirements
- The ideal candidate is a recognized authority in the field, bringing deep scientific expertise, extensive industrial experience, and exceptional leadership capabilities.
- B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc. ), with at least 10+ years of relevant industrial experience in platform specific process development or in supporting platform specific manufacturing operations (e.g. DS Bio, DP SM etc.), PhD is of advantage
- Proven record in the Drug Substance or 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
Responsibilities
- 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
- Deliver on the product’s technical strategic roadmap across the commercial lifecycle, as defined by an end-to-end Product Technical Lead, which includes investigating and mitigating technical risks, implementing improvements, and aligning strategies with broader network objectives
- For resilient or established products in “steady state”, take on an extended role to fully represent and deliver on the technical agenda where no end-to-end Product Technical Lead is assigned. In these cases, the technical product steward holds primary accountability for ensuring DP product quality, reliability, and the execution of long-term strategic goals and operational targets through the effective direction and management of a matrixed team and financial resources
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
