Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
About the role
The Senior Large Molecule DS 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) and Product Technical Health Management (Own & Mitigate Technical Risks):
What they're looking for
- The ideal candidate is a recognized authority in the field, bringing scientific expertise, industrial experience, and leadership capabilities
- 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
- Demonstrated experience with technology transfer and/or with process validation and in pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing
- Strong understanding of regulatory submission and health authority requirements and of of patient needs / patient-centricity as key elements of design and delivery
- Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!
- Relocation benefits are not available for this posting
More about this role
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.
The Senior Large Molecule DS 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...
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