Material Science Product Lead

Roche Pharma Global Technical Operations (PT) delivers a fast evolving portfolio of new Cell & Gene Therapy (CGT) products to bring new curative treatments to patients. This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges with regards to CMC aspects of these products. Especially the understanding of the impact of materials on the performance of the processes and the quality of the products is a key success factor.

The Opportunity:

The Materials Science and Strategy Team integrates material science expertise and data-driven insights into the development of cutting-edge CGT products. This highly dynamic team, composed of material scientists and engineers, collaborates across a variety of clinical and commercial programs to enable Roche's CGT pipeline.

As a Materials Science Product Lead, you will work alongside material scientists, engineers, and multidisciplinary collaborators to drive innovation and ensure robust material life cycle management. Your contributions will be pivotal in delivering strategic solutions for raw material risk mitigation, characterization, and control, ultimately supporting Roche's diverse and groundbreaking CGT pipeline. You will play a key role in advancing CGT products by fostering cross-functional alignment and managing the end-to-end material lifecycle.

• Lead material sub-teams for CGT products, ensuring the development and implementation of phase-appropriate Material Life Cycle Management processes

• Define relevant material attributes, specifications, and controls through raw material attribute assessments and risk assessments

• Drive the material strategy for CGT programs, ensuring seamless collaboration with internal and external stakeholders

• Develop and maintain a digital & analytical innovation framework, including an analytical toolbox for material characterization and release

• Conduct technical due diligence activities with material suppliers and manage relationships with material suppliers, internal sites, and contract manufacturing organizations

• Author and review technical reports, study plans, change records, and other technical documents

• Ensure compliance with cGMPs, SOPs, and other manufacturing documents

Who You Are:

The ideal candidate is motivated, science-driven, curious, and diligent. They aspire to influence their own development and seek a company that offers opportunities to pursue their interests and make an impact across functions and geographies. The qualifications we seek include:

• Bachelor's degree in engineering or life sciences field AND 12+ years relevant biopharmaceutical industry and cGMP experience in CMC, Material Sciences, Process Development, Manufacturing, Regulatory, Quality, or Analytical Development; or Master's degree with 10-13 years; or PhD with 7-10 years

• Experience with CGT Products/ATMPs, such as CAR-T cells or other genetically modified cellular products and/or experience with somatic cell therapies such as iPSC- or hESC-derived products.

• Established expertise and knowledge in raw material analytical characterization, functional and stability testing, material quality/compliance requirements, control strategies, and relevant regulatory frameworks.

• Possess strategic agility and proficiency in business tools, cGMP controls/systems, change management and risk management principles.

• Drive for continuous improvement, and are flexible in ways of working.

• Superb facilitation, negotiation and people skills with the proven ability to support executive-level individuals through decision-making processes.

• Strong written and verbal communication skills in English.

• Ability to build trustful and effective relationships, specifically working in a matrix environment.

• Ability to think strategically and translate strategies into actionable plans.

• Ability to travel domestically and internationally (up to 20% depending on business need) within the Roche manufacturing and supplier network.

Preferred qualifications:

• Experience with complex Advanced Therapy Medicinal Products (ATMP) materials, such as plasmids, gene editing materials/enzymes, cell selection/differentiation reagents, complex proteins/antibodies.

• Experience in drug development and commercialization, and familiar with the multidisciplinary functions involved in drug development. Able to work in a novel area where the regulatory expectations may not be well defined.

• Experience in data analytics, data structures, design of experiments and multivariate data analysis, at development and commercial scale.

The expected salary range based on the primary location of California is $139,000 - 258,100. 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.

Benefits

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