20 beste Stellen als regulatory in bâle bs – aktuell auf Personalsuche

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die Position

As a Scientist in Pharmaceutical Development, you are part of the Department “Pharmaceutical Development” in Pharma Technical Development (PTD) in Basel, Switzerland. The department Pharmaceutical Development is responsible for the development of parenteral drug products (Synthetic molecules and Biologics) from Phase 1 through Launch. Activities encompass formulation and manufacturing process development for parenteral drug products for all clinical stages and the market launch, the transfer of product and process to commercial manufacturing sites, commercial product support and line extension development.

The opportunity

Leading development: Pharmaceutical development of parenteral formulations for clinical development and market (including line extensions). Understanding stability behavior (e.g. biophysics, chemical degradation)
Management of Data: Ensure seamless integration of structured and unstructured data across the department.
Data Mining& Pattern Discovery: Utilize advanced statistical and machine learning techniques to perform deep-dive Data Mining. Identify trends and correlations associated with scientific data.
Functional expertise as project management: Representation of Pharmaceutical Development as pharmaceutical project leader in global CMC teams, functional representative in cross-functional teams and global committees within Roche.
Regulatory submissions: Authoring drug product sections for clinical IND/IMPDs and MAAs.

Who you are

As the successful candidate you hold a Ph.D. degree in chemical/process/bioprocess engineering or related fields Or you hold a masters degree in chemical/process/bioprocess engineering or related fields with a minimum of 3 years of professional (industry) experience in a pharmaceutical company.

Proven experience of establishing and managing large data sets, including exposure to scripting associated with data analysis.
Deep understanding of statistical modeling including linear/logistic regression, cluster analysis, time-series forecasting, longitudinal study data analysis, and multivariate testing.
Knowledge of pharmaceutical product development and associated requirements.
Understanding of regulatory requirements for different clinical and commercial stages of development.
Excellent communication skills and collaborative behaviors, with end-to-end and global thinking, as well as excellent stakeholder management skills

Are you ready to make a difference for our patients? We are looking forward to your application – join us now and become part of our journey!

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

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