Senior​/Principal Scientist in Pharmaceutical Development of Synthetic Molecules; Drug Product

Senior / Principal Scientist in Pharmaceutical Development of Synthetic Molecules (Drug Product) page is loaded## Senior / Principal Scientist in Pharmaceutical Development of Synthetic Molecules (Drug Product) locations:
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Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretend emos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras.

Junte-se à Roche, onde cada voz é importante.### A posiçãoIn PTD, we collaborate to develop robust manufacturing processes and quality control systems to efficiently transform scientific ideas into products. We reliably deliver 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). Within PTDC-P, we transform molecules to medicines through particle engineering, and develop and deliver customised clinical formulations and robust commercial drug products that benefit patients.### The Opportunity 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, including scientists and management from other disciplines (chemistry, analytics, quality, regulatory, and commercial production), and you represent the department on technical development teams (CMC) and scientific boards. Furthermore, you are driving scientific initiatives to ensure the department's scientific and technical excellence.

The main responsibilities of this challenging position include:
* Development and optimisation of clinical as well as commercial formulations and manufacturing processes for oral solid drug products using various manufacturing technologies (i.e. batch and continuous mode), including the scale-up and transfers to commercial manufacturing sites to facilitate the successful process validation at the sites.
* Development and implementation of new and innovative drug delivery technologies that can be applied in regular portfolio projects.
* Application of statistical tools (e.g. DoEs), risk assessment tools for QbD (e.g. QRA, FMEA) and Modelling and Simulation tools.
* Regular review of scientific literature to extract relevant trends and integrate innovative concepts and technologies in the scientific strategy of the department.
* Active participation in scientific teams at Roche as well as external consortia.
* Authorship and review of technical reports, manufacturing instructions, process validation documents, and the CMC parts of regulatory submissions to support market authorisation.
* Contributing actively to the intellectual property values protection of our Roche products.
* Active sharing of own knowledge/experience with other scientists in regular exchange meetings and as a project consultant or mentor.### Who you are
* 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 and remains highly adaptable to organisational change.
* You combine a coaching mindset with excellent…