Senior Large Molecule DS Product Steward
Roche
Summary
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.
Job description
Main Responsibilities
- 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.
Who You Are
- 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 patient needs / patient-centricity as key elements of design and delivery.
Requirements
- B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc.)
- 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 as well as process development in the field of biological molecules
- Demonstrated experience with technology transfer and/or process validation and in pharmaceutical quality systems and industry-wide guidelines
- Strong understanding of regulatory submission and health authority requirements
- Understanding of patient needs / patient-centricity as key elements of design and delivery
Benefits
- Discretionary annual bonus
- Relocation benefits not available
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.