Senior Large Molecule DS: Technical Industrialization Lead

F. Hoffmann-La Roche AG; Oceanside (CA); On-site; USD 132,000 - 244,000; Full time

Job summary

Genentech, a member of the Roche group, seeks a Senior Large Molecule DS Product Steward to lead technical industrialization and maintain the product's technical health from manufacturability decisions through PPQ and supply maturity. You will own risk mitigation and drive improvements across the commercial lifecycle.

You will collaborate with site leadership and quality teams, aligning strategies with network objectives and regulatory expectations while overseeing product governance and

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.
• 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.

Responsibilities

• Drive seamless technical industrialization and sustaining and improving the technical health of commercial products through PPQ, supply maturity and optimization.
• Deliver on the product’s technical strategic roadmap across the lifecycle, identifying risks and implementing improvements.
• Represent the product in key technical governance forums and with senior stakeholders.
• Serve as the primary product technical owner for site leadership and quality functions across the lifecycle.

Skills

Industrial experience in DS/DP

Process development

Technology transfer

Regulatory submission understanding

Quality systems knowledge

Education

B.S./M.S. in biotechnology/pharmacy/biology

PhD (advantage)

Job description

Genentech, a member of the Roche group, seeks a Senior Large Molecule DS Product Steward to lead technical industrialization and maintain the product's technical health from manufacturability decisions through PPQ and supply maturity. You will own risk mitigation and drive improvements across the commercial lifecycle.

You will collaborate with site leadership and quality teams, aligning strategies with network objectives and regulatory expectations while overseeing product governance and