Schweiz, Basel-Stadt, Basel
Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.
Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.
“Small Molecules Technical Development” (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), and analytical sciences, and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small Molecules (PTC) and PTD. PTDC is responsible for late stage technical development of our small molecules (SM) pipeline and the manufacture of DS and DP for clinical studies across our SM manufacturing network.
The Late Stage Analytical Development department is part of Global Technical Development and globally responsible for developing state-of-the-art analytical methods, analyzing dosage forms of small molecule development products and preparing the analytical dossier for submission to health authorities.
As an Analytical Scientist you are together with the analytical group head responsible for the following main tasks:
- Close, outcome-oriented collaboration with product manufacturers, Regulatory Affairs, QA and analytical partners (early development, IPC, active substances and commercial products) in the technical development team.
- International coordination of the relevant analytical activities,
- Efficient "time to market"-driven analytical support for pharmaceutical development products and licensed products.
- Comprehensive analytical activities (generation of basic physical and chemical data for a substance, successive improvement and validation of analytical test methods, analytical control, generation of packaging-specific stability data and ensuring adequate documentation)
- Providing support for the group head (revising and authoring SOPs governing the organisation of and procedures in the section and department)
- Organizing, deploying, instructing and developing line reports and implementing existing policies, guidelines and SOPs in all report groups.
- At least Master of Science degree in organic/analytical chemistry or pharmaceutics. PhD is of advantage
- Working style driven by initiative, team focus, responsibility and flexibility
- Excellent organisational skills
- Independent, efficient and reliable attitude
- Good knowledge of MS Office
- Very good German and English language skills
- Applications of career entrants are welcome