Formulation Project Leader / Formulation Project Leaderess

Job Summary

Location: Basel, Switzerland

Role Purpose

As a Formulation Project Leader in Oral Late Phase Development (NCE), you will lead and manage the formulation and process development of oral solid dosage forms from lab-scale through scale-up and transfer to commercial scale, in close collaboration with the Drug Product Subteam. Development activities will include, among other tasks, formulation and process design and optimization, quality risk management, as well as scientific writing of development documents and GMP documentation. This role places special emphasis on applied data science and mechanistic modeling as essential tools for data-driven and efficient process development and scale-up.

About the Role

Your responsibilities will include but are not limited to:

• Passion for innovative formulations and technologies, along with experience in enabling formulation development.
• Understanding the value of data-centric, computational models to guide formulation and manufacturing process development.
• Driving scientific excellence in the development and manufacturing of standard and enabling formulations of oral drug products (NCE), supported by data-driven conclusions and mechanistic modeling.
• Collaborating closely with the Drug Product Sub-Team and Transfer Team members to identify, understand, and manage critical aspects concerning Drug Substance, Drug Product, Analytics, Packaging, and Device.
• Maintaining regular exchanges with key experts in Technology Focus Groups, Modelling & Simulation, Biopharmaceutics, and further networks to integrate their guidance into development strategies and project plans.
• Authoring sound scientific and well-structured development and GMP documents to facilitate the commercial manufacturing of new Drug Products.
• Contributing to the generation of CMC submission dossiers, and supporting Drug Product-related inquiries from Health Authorities and Inspectors.

What You’ll Bring to the Role

• Advanced degree (minimum PhD) in a relevant scientific field (e.g., Pharmaceutical Technology, Chemical Engineering).
• Minimum 2 years of successful industry experience in the development of pharmaceutical formulations, focusing on formulation and process development of standard and enabling formulations for small molecules (NCE), and scale-up of manufacturing processes for commercialization.
• Knowledge of data science and data visualization, with ideally prior experience in applying data-centric, computational models to guide process development.
• Interdisciplinary thinking and a keen interest in collaboration with other functions.
• Broad and profound understanding of formulation development activities.
• Knowledge of laboratory and technical tools (e.g., QbD, PAT) as well as relevant GLP and GMP regulations and policies.
• A demonstrated track record of creativity and problem-solving in projects.
• Effective communication, organizational, planning, and negotiation skills.
• Strong scientific and technical writing skills.

Commitment to Diversity and Inclusion

Novartis is dedicated to fostering an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities we serve.

Accessibility and Accommodation

Should you require reasonable accommodation for any part of the recruitment process due to a medical condition or disability, or if you need further detailed information about the essential functions of this position, please send an email to Show e-mail. Include the nature of your request, your contact information, and the job requisition number in your message.

Why Novartis

At Novartis, we believe that helping people with diseases and their families requires more than just innovative science. It takes a community of smart, passionate individuals like you, who collaborate, support, and inspire each other to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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Benefits and Rewards

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Application Process

Apply online using the form below. Please note that only applications matching the job profile will be considered.

Division: Development
Business Unit: Innovative Medicines
Location: Switzerland
Site: Basel (City)
Company / Legal Entity: C028 (FCRS = CH028) Novartis Pharma AG
Functional Area: Research & Development
Job Type: Full time
Employment Type: Regular
Shift Work: No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams that reflect the patients and communities we serve.