Global Head, Pharma Biologics Drug Substance Development in Penzberg bei Roche

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***Please note that equal consideration will be given to candidates for any of the listed site locations.***

Pharma Global Technical Operations (PT) is the organization that manufactures and delivers Roche’s groundbreaking therapies to 127 million patients around the world. PT is involved in producing every Roche medicine – from the development process through clinical trials – and continuing to product maturity. Our organization coordinates all aspects of production of Roche medicines in all disease areas and dosage forms.

Pharma Technical Development (PTD) is integral to Roche’s mission to develop innovative and transformative meaningful medicines for patients by applying leading technical expertise to bridge early-stage, late-stage and commercial product needs.

You, the Global Head of Pharma Biologics Drug Substance Development, are responsible for setting the strategic direction of the organization globally and for driving effective delivery outcomes contributing to Pharma Vision, R&D effectiveness and efficiency, and PT North Stars. You will be responsible for leading all aspects of drug substance development for biologics including:

• Upstream bioprocessing activities such as high throughput research material generation, GMP cell banking, cell line development, and early and late stage cell culture processes.

• Downstream bioprocessing activities such as QC microbiology, adventitious agents testing, process virology R&D and validation, purification processes development and transfer to manufacturing operations from non-clinical studies to the registration stage of biologics

• Integrated in-process testing strategies in support of E2E process development and control

• Process design, development, and validation using quality by design

You will partner with peer global leaders of Biologics Pharmaceutical Development, Biologics Analytical Development and Quality Control (ADQC) and Biologics Clinical Manufacturing and Supply to collectively deliver on our Global Biologics Technical Development aspirations. This includes shared accountability for the cross-functional operating model to effectively deliver the full Biologics pipeline from early stage development through licensure and launch, seamless engagement end-to-end with Biologics collaborators, and sound leadership of our Technical Development community locally and globally. You also play a central role in collaborating with Roche Pharma’s Cell & Gene Therapy Development organization

The organization is also responsible for providing technical support and oversight at CMOs and internal manufacturing sites for technology transfers, launch, commercial product supply and life cycle management including developing and implementing improved cell lines and upstream/downstream processes. The individual is a champion for technology development that brings value to customers (e.g. Manufacturing) and patients (e.g. speed and reduced COGs).

You will build and sustain a high-performing and agile organization fostering an environment of inclusion, innovation, collaboration, and people engagement. You will foster partnerships across the Pharma value delivery chain in Roche Early Research and Development (gRED/pRED), Chugai, Global Product Development (GPD), Global Product Strategy (GPS), Partnering, and Pharmaceutical Tech Operation (PT). You will work closely with PT Biologics R&D functions to seamlessly deliver the pipeline. As a member of the PTD Leadership Team you will deploy Pharma and PT strategies needed to effectively and efficiently deliver the company’s exciting, large, and diverse pipeline. You have a passion for leading PTD into an elite development organization and being the benchmark for the industry. As a successful candidate, you have a demonstrated track record in developing the future leaders. You practice VACC (Visionary, Architect, Catalyze, and Coach) and Lean Leadership, and are role models for the PT community leaders with respect to performance, collaboration, organization development, and business outcomes.

You will lead a team consisting of 370+ permanent and contingent scientific employees based in South San Francisco (US) and Penzberg (Germany) and are accountable for a portfolio that consists of approximately 50+ development projects and second generation of commercial products in a variety of therapeutic areas including immunology, ophthalmology, on