<< ZURÜCK
BEWERBEN
von: Innovative Medicines
Summary
Formulation Project Leader – Oral Dosage Forms (80-100%)
Novartis holds a rich development portfolio of small molecules ready to develop into innovative patient centric oral dosage forms. As a Formulation Project Leader working on oral dosage forms, you will lead and manage formulation and manufacturing activities linked to pharmaceutical development for small molecules (New Chemical Entities; NCE) for assigned projects. Your projects will be mainly in post-PoC phase. You develop and transfer manufacturing processes and control strategies according to QbD principles. You are knowledgeable in applied data science, apply advanced data processing and handling and you experienced with mechanistic modelling and simulation of pharmaceutical unit operations. You are authoring technical source documents for global filings. You work in a cross-functional team with operations, analytics, particle engeeniring and biopharmaceutical and modelling experts, QA and project management.
About the Role
Your responsibilities will include but are not limited to:
- You define, own and drive formulation development and manufacturing activities at internal or external manufacturing sites for assigned projects in line with the project plan, guidelines and procedures. You guide and collaborate with operational colleagues working on your process.
- You ensure authoring of correct, comprehensible, structured, complete and legible scientific development reports and GMP Supply documents to plan, interpret and report development trials, process transfers and supply activities.
- You closely collaborate with DP sub-team members. You understand, identify and manage with them together critical aspects around DS, DP, packaging, device and analytics.
- You apply data-centric ways of working by contributing and implementing digital transformation initiatives in development activities.
- You are knowledgeable in advanced data processing and handling.
- You contribute the modeling and simulation in the formulation and process development activities.
- You are a member of the Manufacturing Processes Transfer Team with representatives from Formulation, Analytics, Packaging and QA as well as respective experts and functions of the launch site, which plans, owns, executes, assesses and documents process transfer and verification activities.
- You contribute to the generation of filing dossiers, answer DP related questions in inspections and support Health Authority requests.
What you’ll bring to the role:
- Advanced degree (minimum PhD) in a relevant scientific field
- Minimum 3 years of industry experience in the development of pharmaceutical formulations for small molecules and experience applying data science and modeling & simulation in the development of pharmaceutical products
- Good knowledge of laboratory and/or technical tools (e.g PAT, IPCs) and Quality by Design concept
- Excellent scientific skills and technical writing skills
- Interdisciplinary thinking and interest in collaboration with other functions
- Successfully demonstrated track record of creativity and problem solving in projects.
- Good communication, organizational, planning and negotiation skills (German language skills desired).
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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<< ZURÜCK
BEWERBEN