Senior Large Molecule DS Product Steward

About the role

Roche's global Manufacturing Science and Technology (gMSAT) department owns the process and product of its commercial products, including drug substance and drug product networks, new technologies, network standardization and technical risk mitigation. The Senior Large Molecule DS Product Steward drives seamless technical industrialization and sustains and improves the technical health of commercial products, from manufacturability decisions through process performance qualification (PPQ), supply maturity and optimization to divestment.

Key responsibilities

• Identify, define and deliver drug substance (DS)-related technical industrialization strategies and improvements so the product launches successfully and stays validated, robust, cost-effective and compliant.
• Deliver the product's technical strategic roadmap across its commercial lifecycle, investigating and mitigating technical risks, implementing improvements and aligning with broader network objectives.
• Act as primary product technical owner for site leadership and quality functions when investigating product or process issues.
• Represent the product in key technical governance forums and senior stakeholder interactions.

Required profile

• B.S. or M.S. 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).
• PhD is an advantage.
• Recognized authority in the field, with scientific expertise, industrial experience and leadership capabilities.

Required skills

• Proven record in drug substance or drug product manufacturing, product and technology industrialization and process development for biological molecules.
• Experience with technology transfer and/or process validation, and pharmaceutical quality systems and industry guidelines for platform-specific manufacturing.
• Strong understanding of regulatory submission and health authority requirements.

What we offer

• Expected salary range of $131,500 to $244,300 for the California location, depending on experience, qualifications and location.
• A discretionary annual bonus may be available based on individual and company performance.
• The position qualifies for the benefits described in the original listing.
• Relocation benefits are not available for this posting.