Principal Product

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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 commercial products, encompassing internal and external drug substance and drug product sites, new technology implementation, network standardization, and mitigation of technical risks. The gMSAT team is structured with product-focused Large Molecule and Synthetic Molecule (Drug Substance & Drug Product), Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams, operating in cross-functional squads and circles.

The Principal Product & Process Steward (Synthetic Molecules) 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 are:

• Identify, define, and deliver DS (Drug Substance) or DP (Drug Product)-related technical industrialization strategies and technical improvements to ensure successful launch as well as that the product remains validated, robust, cost-effective, and compliant, while also acting as the deep subject matter expert (SME) for the underlying manufacturing process platform.

• Act as a key connector between gMSAT and the internal/external manufacturing sites, serving as a highly specialized and execution-focused subject matter expert (SME) for the process platform

• Deliver on the product's technical strategic roadmap across the commercial lifecycle, as defined by a Product Technical Lead, which includes investigating and mitigating technical investigations and risks, implementing improvements, and aligning strategies with broader network objectives.

• Serve as a primary product technical owner for site leadership and quality functions when investigating product or process issues across the commercial lifecycle. This includes providing hands-on, second-level technical support for complex investigations, CAPAs, and troubleshooting in close partnership with local MSAT functions and the internal/external manufacturing network.

• Represent the product in key technical governance forums and senior stakeholder interactions

• For marketed synthetic molecule products where no Product Technical Lead is assigned, take on an extended role as End-to-End Product Steward, leading the Product Technical Team and fully representing and delivering on the technical agenda. In these cases, you hold primary accountability for ensuring functional (e.g. DS, DP, Device & Packaging) 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. 

• Take on this matrix leadership accountability for multiple synthetic molecule products

You are recognized by peers and functional leaders as an authority in your field within the industry and you have a proven record in the Drug Substance or Drug Product manufacturing and product and technology industrialization as well as process development in the field of synthetic molecules.

• A B.S. or M.S. degree in a scientific discipline (chemistry, pharmacy, engineering, or a related technical field in synthetic molecules), with at least 10+ years of relevant industrial experience in platform specific product or process development or in supporting platform specific manufacturing operations (e.g., synthetic molecule drug substance, drug product, etc).  A PhD is an advantage.

• Demonstrated expertise in the manufacturing of parenteral synthetic molecules is an advantage.

• Significant cross-functional matrix leadership experience

• Demonstrated experience in pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing and with technology transfer and/or with process validation and in depth conceptual and practical knowledge in platform specific technology, processes and equipment

• Strong understanding of regulatory submission and health authority requirements and deep understanding 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

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Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.