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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.
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.
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.
You bring hands-on experience applying data analytics to pharmaceutical development, CMC, formulation, stability or process development datasets, including scripting in Python, R or similar tools.
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!
A 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.