A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
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 design, develop, supply, and register clinical stage products globally.Within PTD, Synthetic Molecules Technical Development (PTDC) leverages advanced science and technology to drive the development of synthetic molecules from first-in-human studies through commercialization. Based in Basel, Switzerland, our team of approximately 700 experts works collaboratively to bring our vision to life, delivering impactful solutions that support our mission and uphold our core values.
As the Head Process Chemistry & Catalysis, you will be leading the Process Chemistry & Catalysis department and will be a member of the Synthetic Molecules Technical Development leadership team. You will be responsible for end-to-end Drug Substance synthesis design and process development using state of the art science and technologies and the external workbench (CDMOs, Institutes and Universities) to deliver the company’s portfolio of synthetic molecules (including oligonucleotides & peptides) from entry into human through transfer to commercial manufacturing, including authoring & optimal support of regulatory submissions. You will be reporting to the Head of Synthetic Molecules Technical Development.
The Opportunity
- Lead together with your leadership team the Process Chemistry & Catalysis department comprising approximately 90 team members in total, including scientists, associates, post docs, internships, and apprentices, in alignment with the Roche Leadership Commitments.
- Drive the development of sustainable, cost-efficient, and robust processes and foster enhanced process understanding using cutting-edge science and technologies to support lean manufacturing.
- Promote scientific excellence throughout the entire process chemistry lifecycle, from early route design to transfer to commercial manufacturing, encompassing from the raw materials to the drug substances for Roche’s synthetic molecules (small molecules, oligonucleotides, and peptides).
- Provide scientific and technical guidance to project teams and external collaboration partners in designing and developing manufacturing processes and associated control strategies, employing state-of-the-art science and methodologies.
- Foster innovation and the implementation of new technologies and support the departmental efforts in robotics, digitalization, and modeling and simulation to build an industry-leading organization.
- Play an active role in defining the future technical and regulatory strategies and concepts of Synthetic Molecules Technical Development.
Who you are
You have a PhD degree in organic chemistry with at least 15 years of experience in process chemistry for synthetic molecules (including small molecules, oligonucleotides and peptides), spanning the entire range from route design, process development, process optimization and characterization and process transfer to manufacturing. Further:
- You have a proven track record as an experienced leader and excellent scientist with a profound knowledge in organic synthesis and chemical process technologies as well as in manufacturing in a GMP environment. This is demonstrated by publications in scientific literature and patent applications.
- Excellent knowledge of the chemistry of classical small molecules, oligonucleotides and peptides and extensive experience in working with external collaboration partners (institutes, universities and CDMOs).
- Comprehensive understanding of sustainable process development and how to implement green chemistry and lean concepts into manufacturing processes.
- Profound experience in CMC regulatory, not only in writing and reviewing scientific reports and regulatory documents, including briefing packages and NDAs/MAAs, but also in shaping regulatory and scientific strategies and concepts together with internal experts, consortia and agencies.
- Excellent communication skills and a strong ability of building and maintaining constructive and effective relationships with stakeholders as well as strong collaboration and team building skills.
For more information and to apply visit https://careers.roche.com/global/en/job/202504-108511/Head-Process-Chemistry-Catalysis