Formulation Project Leader / Formulation Project Leaderess

Job ID: REQ-10048565

Date: May 08, 2025

Location: Basel, Switzerland

Summary

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. This role requires close collaboration with the Drug Product Subteam. Key development activities include formulation and process design and optimization, quality risk management, and the scientific writing of development and GMP documentation. Special emphasis is placed on experience in applied data science and mechanistic modeling to enable data-driven and efficient process development and scale-up.

About the Role

Your responsibilities will include but are not limited to:

• A passion for innovative formulations and technologies, with experience in enabling formulation development.
• Understanding the value of applying data-centric, computational models to guide formulation and manufacturing process development.
• Driving with scientific excellence the formulation development and manufacturing work of standard and enabling formulations and processes for 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 Devices.
• Maintaining regular exchanges with key experts in areas such as Technology Focus Groups, Modeling & Simulation, Biopharmaceutics, and other networks, integrating their guidance into development strategies and project plans.
• Authoring well-structured scientific and development documents, as well as GMP documents, to enable 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).
• A minimum of 2 years of successful industry experience in the development of pharmaceutical formulations, specifically in formulation and process development for small molecules (NCE) and scale-up of manufacturing processes into oral drug products for commercialization.
• Knowledge of data science and data visualization, with experience in applying data-centric, computational models to guide formulation and manufacturing process development.
• Interdisciplinary thinking and a strong interest in collaboration with other functions.
• A broad and profound understanding of formulation development activities.
• Familiarity with laboratory and/or technical tools (e.g., QbD, PAT) as well as knowledge of 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 abilities.

Commitment to Diversity and Inclusion

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

Accessibility and Accommodation

Novartis is dedicated to working with and providing reasonable accommodations to all individuals. If you require reasonable accommodations for any part of the recruitment process due to a medical condition or disability, or if you would like more details about the essential functions of a position, please reach out via email at inclusion.switzerland@novartis.com. Include your request and contact information, along with the job requisition number.

Why Novartis?

Helping people with diseases and their families requires more than innovative science; it necessitates a community of smart, passionate individuals like you. Collaborating, supporting, and inspiring one another leads to breakthroughs that can transform patients' lives. Ready to create a brighter future together?

Join our Novartis Network

If this role is not the right fit for you, consider joining our talent community to stay connected and learn about upcoming career opportunities: Talent Network.

Benefits and Rewards

Learn more about the various ways we support your personal and professional growth in our benefits handbook: Benefits & Rewards.

To apply online, please use 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 representative of the patients and communities we serve.