Senior Large Molecule DS Product Steward
Responsible for driving seamless technical industrialization and sustaining and improving the technical health of commercial products. In this role you will manage DS‑related technical industrialization strategies, technical improvements, and product technical risk management across the commercial lifecycle.
Key Responsibilities
* Identify, define, and deliver DS‑related technical industrialization strategies and technical improvements to ensure successful launch and to maintain product validation, robustness, cost‑effectiveness, and compliance.
* Deliver on the product’s technical strategic roadmap across the commercial lifecycle, as defined by an end‑to‑end Product Technical Lead; this includes investigating and mitigating technical risks, implementing improvements, and aligning strategies with broader network objectives.
* Serve as the 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.
Qualifications
* 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.); Ph.D. is an advantage.
* Proven record in drug substance or drug product manufacturing, product and technology industrialization, and process development in the field of biological molecules.
* Demonstrated experience with technology transfer and/or process validation in pharmaceutical quality systems and adherence to industry‑wide guidelines pertinent to platform‑specific process development and manufacturing.
* Strong understanding of regulatory submission and health authority requirements, and of patient needs / patient‑centricity as key elements of design and delivery.
Roche is an Equal Opportunity Employer.
Location: Basel, Switzerland
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