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):

• Identify, define, and deliver DS-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.

• 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

• The ideal candidate is a recognized authority in the field, bringing scientific expertise, industrial experience, and leadership capabilities.

• B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc. ), with 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.), 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.

• 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.

The expected salary range for this position based on the primary location of California is $131,500 to $244,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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.

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