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Roche is seeking a highly motivated Senior or Principal Scientist to join the crystallization and solid state development teams at Roche in Basel, Switzerland. You will design, optimize, and scale crystallization processes to achieve target purity and polymorph control, while collaborating with chemistry, formulation, and production teams.
The role emphasizes strong project leadership, cross-functional teamwork, and regulatory documentation exposure, with a focus on digitalization to improve
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Roche is seeking a highly motivated and passionate Senior or Principal Scientist to join the crystallization and solid state development teams at Roche in Basel, Switzerland. The successful candidate will work in the Particle Design section within the small molecule organization and develop and scale up novel crystallization and precipitation processes in close collaboration with chemistry and formulation colleagues in development and production. The ideal candidate will have a strong background in crystallization, filtration and drying, and have the ability to apply chemistry and chemical engineering principles to solve challenging problems. Additionally, the candidate should have a strong affinity for digitalization to drive innovation and efficiency in process development.
As part of the crystallization team, you will work in a highly dynamic and cross-functional environment within the PTDC-P organization. You will be responsible for developing chemical processes that achieve the necessary purity, crystal form (polymorph) and particle properties. The successful candidate is additionally expected to drive research efforts and implement new technologies that solve key CMC problems.
The position is located at the interface between synthetic and analytical chemistry and formulation and requires close collaboration with functional stakeholders. The candidate should exhibit excellent interpersonal skills for effective collaboration with interdisciplinary teams and demonstrate a solid understanding of end-to-end process development for small molecules. Frequent presentations and team interactions are expected. The candidate will also be responsible for authoring filing documents to regulatory authorities.
Design, optimize, and scale phase-appropriate crystallization, precipitation, and isolation processes under non-GMP and cGMP conditions to achieve target purity, crystal forms (polymorphs), and physical particle attributes.
Define commercial manufacturing design spaces and operating ranges, ensuring robust control over drug substance quality attributes through a mechanistic understanding of underlying physical chemistry principles.
Serve as a key technical interface within the Particle Design section (PTDC-P) in Basel, bridging synthetic chemistry, analytical development, production, and formulation to resolve complex solid-state pipeline challenges.
Drive innovation and digital transformation by applying advanced process development tools, molecular or process modeling, and new solid-state methodologies to optimize particle properties.
Author and review comprehensive technical reports, cGMP manufacturing instructions, process validation documentation, and key technical sections for regulatory filing submissions.
Lead internal and external matrix collaborations, coordinating with cross-functional project teams, vendors, and academic partners to solve complex CMC (Chemistry, Manufacturing, and Controls) challenges.
Expand unit operation strategies by leveraging techniques such as wet/dry milling, spray drying, or co-processing, especially for challenging small molecules, peptides, or semicrystalline materials.
Actively contribute to and advance the internal and external scientific community by sharing technical expertise, presenting research findings, and implementing cutting-edge technologies.
Ph.D. in Chemical Engineering, Physical Chemistry, Materials Science, Pharmaceutical Science, or a related field with 0-5 years of pharmaceutical industry experience (or an M.Sc. with 7-15+ years of relevant industry experience).
Proven scientific expertise in end-to-end small molecule crystallization, filtration, drying, and purification processes, supported by a strong foundation in solid-state chemistry and polymorphism.
Hands-on familiarity with physical powder/particulate characterization techniques and process technologies like wet/dry milling, spray drying, precipitation, or process/molecular modeling.
Demonstrated track record in project management, matrix leadership, and agile decision-making, with the ability to prioritize and drive deliverables in a dynamic environment.
Strong collaborative mindset with exceptional interpersonal and communication skills, enabling effective cross-functional work across chemistry, formulation, and production teams.
Proactive problem-solver and innovative thinker who thrives on troubleshooting complex experimental challenges, embracing new ideas, and translating scientific concepts into scalable solutions.
Excellent command of written and spoken English for technical documentation and global presentations; working knowledge of German and experience authoring regulatory filing documents are strong assets.
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