At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionIn PTD, we collaborate to develop robust manufacturing processes and quality control systems to efficiently transform scientific ideas into products, reliably delivering quality products to patients enrolled in clinical studies around the world. We excel in our work by creating an engaging and inclusive environment where everyone can bring their skills and talents to developing innovative medicines. This position is part of the Synthetic Molecule Pharmaceutical and Solid State Development organisation (PTDC-P), where we transform molecules to medicines through particle engineering and develop and deliver customised clinical formulations and robust commercial drug products that benefit patients.As a Senior Scientist / Principal Scientist in Drug Product Development, you are responsible for developing robust formulations and lean manufacturing processes for oral dosage forms of new chemical entities. In this position, you work closely with international teams across various disciplines (chemistry, analytics, quality, regulatory, and commercial production), represent the department on technical development teams (CMC) and scientific boards, and drive scientific initiatives to ensure the department's scientific and technical excellence.The OpportunityThe main responsibilities of this challenging position include:Developing and optimizing clinical and commercial formulations and manufacturing processes for oral solid drug products using various technologies (i.e., batch and continuous mode), including scale-up and transfers to facilitate successful process validation at commercial sites.Developing and implementing new and innovative drug delivery technologies that can be applied in regular portfolio projects.Applying statistical tools (e.g., DoEs), risk assessment tools for QbD (e.g., QRA, FMEA), and Modelling and Simulation tools.Regularly reviewing scientific literature to extract relevant trends and integrate innovative concepts and technologies into the scientific strategy of the department.Authoring and reviewing technical reports, manufacturing instructions, process validation documents, and the CMC parts of regulatory submissions to support market authorisation.Actively participating in scientific teams at Roche and external consortia, while actively contributing to the intellectual property values protection of our Roche products.Actively sharing your knowledge and experience with other scientists in regular exchange meetings, and serving as a project consultant or mentor.Who You AreTo be successful in this role, you bring the following qualifications:You hold a PhD or Master-s in Pharmaceutical Technology or Chemical/Process Engineering, backed by 5-10 years of experience in the development of oral dosage forms.You possess broad expertise in the drug product lifecycle, including the authorship of CMC regulatory dossiers, and a preference for direct, professional interaction with health authorities.You excel at managing external partnerships, demonstrating a strong ability to lead and collaborate effectively with CDMOs.You are a results-driven innovator who applies "out of the box" thinking to implement technical solutions, remains highly adaptable to organisational change, and demonstrates high professional flexibility, including occasional travel to meet project and stakeholder needs.You combine a coaching mindset with excellent communication skills, thriving as a fair team player who can work both independently and cross-functionally.Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity! Who we areA healthier future drives us to innovate. Together, more than 100-000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let-s build a healthier future, together.Roche is an Equal Opportunity Employer.
