Formulation Project Leader / Formulation Project Leaderess

Job ID

REQ-10048565

May 08, 2025

Switzerland

Summary

Location: Basel, Switzerland

Role Purpose: As a Formulation Project Leader in Oral Late Phase Development (NCE), you will lead and manage 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 formulation and process design, optimization, quality risk management, as well as scientific writing of development documents and GMP documentation. A keen interest and experience in applied data science and mechanistic modeling will be essential in enabling data-driven and efficient process development and scale-up.

About the Role

Your responsibilities will include but are not limited to:

• You have a passion for innovative formulations and technologies and bring experience in enabling formulation development.
• You understand the value of applying data-centric, computational models to guide formulation and manufacturing process development.
• You drive scientific excellence in the formulation development and manufacturing work of both standard and enabling formulations for Oral Drug Products (NCE), supported by data-driven conclusions and mechanistic modeling.
• You collaborate 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.
• You maintain regular communication with key experts in areas such as Technology Focus Groups, Modeling & Simulation, and Biopharmaceutics, integrating their guidance into the development strategy and project plans.
• You author well-structured scientific development documents as well as GMP documents to enable the commercial manufacturing of new Drug Products.
• You contribute to the generation of CMC submission dossiers and support 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).
• A minimum of 2 years of successful industry experience in the development of pharmaceutical formulations, focusing on formulation and process development for small molecules (NCE) and scale-up of manufacturing processes into oral drug products.
• Knowledge of data science and data visualization, with experience applying data-centric, computational models to guide formulation and manufacturing process development.
• Interdisciplinary thinking and a desire to collaborate with other functions.
• A broad and profound understanding of formulation development activities.
• Good knowledge of laboratory and/or technical tools (e.g., QbD, PAT), as well as relevant GLP and GMP regulations and policies.
• A successful 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 creating an outstanding, inclusive work environment and diverse teams that represent the patients and communities we serve.

Accessibility and Accommodation

Novartis is committed to providing reasonable accommodations to all individuals. If you require accommodation due to a medical condition or disability or need more detailed information about the essential functions of this position, please send an email to Show e-mailm">Show e-mail with your request and contact information. Please include the job requisition number in your message.

Why Novartis

Helping people with disease and their families takes more than innovative science. It requires a community of smart, passionate individuals like you, collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn More

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Benefits and Rewards

Discover all the ways we support your personal and professional growth in our benefits handbook: Explore Benefits

Application Process

Apply online using the form below. Only applications matching the job profile will be considered.

Company Information

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 representative of the patients and communities we serve.