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Roche

Senior Large Molecule DS Product Steward

Roche

. Drive seamless technical industrialization and sustain and improve the technical health of commercial products from manufacturability decision through process performance qualification, supply maturity and optimization, and divestment .

Posted 9/17/2026full-timeSouth San Francisco • California • United StatesSenior💰 $131,500 - $244,300 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in Drug Substance and Drug Product manufacturing, with a strong focus on technical industrialization strategies and process development for biological molecules. Proven ability to navigate regulatory requirements and implement quality systems while aligning product strategies with patient-centric design.

Highest-signal resume keywords
Drug Substance ManufacturingProcess DevelopmentTechnology TransferRegulatory SubmissionPharmaceutical Quality Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Process Performance QualificationTechnical Risk MitigationTechnical Roadmap DevelopmentProduct Technical OwnershipProcess Validation
Soft Skills
Stakeholder InteractionCross-Functional Collaboration
Industry Keywords
BiotechnologyPharmacyBiological MoleculesPatient-CentricityHealth Authority Requirements

About the role

Key responsibilities & impact
  • Drive seamless technical industrialization and sustain and improve the technical health of commercial products from manufacturability decision through process performance qualification, supply maturity and optimization, and divestment
  • Identify, define, and deliver Drug Substance-related technical industrialization strategies and technical improvements
  • Develop and deliver the product’s technical strategic roadmap across the commercial lifecycle
  • Investigate and mitigate technical risks
  • Implement technical improvements and align strategies with broader network objectives
  • Serve 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

Requirements

What you’ll need
  • B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc.); PhD is of advantage
  • At least 7+ years of relevant industrial experience in platform specific process development or in supporting platform specific manufacturing operations
  • Proven record in Drug Substance or Drug Product manufacturing and product and technology industrialization
  • Experience with process development in the field of biological molecules
  • Experience with technology transfer and/or process validation
  • Experience 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
  • Understanding of patient needs / patient-centricity as key elements of design and delivery

Benefits

Comp & perks
  • A discretionary annual bonus may be available based on individual and Company performance
  • Benefits detailed at the link provided below