Formulation Project Leader (Early Phase)

Summary

Location: Basel, Switzerland #onsite

Role Purpose:
We are looking for a collaborative and scientifically strong professional to bring together formulation project leadership and biopharmaceutic expertise across innovative oral drug product development programs. In this role, you will guide formulation and manufacturing activities for small-molecule oral dosage forms while deepening the understanding of how molecular properties, formulation design, and process parameters influence absorption, bioavailability, and in vivo performance. Working across TRD, PHAD, PK Sciences, Translational Medicine, and development sub-teams, you will help shape integrated, data-driven strategies that support development from first-in-human studies through scale-up, transfer, and regulatory submission.

About the Role

Key Responsibilities

• Lead formulation development and manufacturing process activities for oral dosage forms, from early clinical phases through final formulation and process definition, for Phase 3 and beyond.
• Develop and maintain integrated project plans that connect formulation, control strategy, biopharmaceutic assessments, bridging strategies, and supply activities with overall program objectives.
• Provide scientific insight into the relationship between drug substance properties, dosage form design, dissolution, permeability, absorption, and in vivo performance.
• Design, interpret, and integrate in vitro, in silico, and in vivo biopharmaceutic studies to support formulation selection and development decisions.
• Contribute as a key partner within cross-functional drug product sub-teams and collaborate closely with Pharmaceutical Development, Chemistry & Analytical Development, PK Sciences, Translational Medicine, and technical operations.
• Contribute to scientific documentation and support CMC and development dossiers, including responses to health authority questions and regulatory inspections.
• Apply innovative approaches such as predictive modeling, biorelevant testing, quality-by-design principles, and digital methods to formulation and biopharmaceutic development.
• Share knowledge, support colleagues, and help strengthen scientific capabilities across teams.

What You’ll Bring

• Advanced degree in Pharmaceutical Sciences, Pharmaceutical Technology, Chemical Engineering, Chemistry, or a related scientific field; PhD or equivalent experience is valued.
• Relevant industry experience in formulation development and/or biopharmaceutics within pharmaceutical development, ideally for small-molecule oral dosage forms.
• Broad understanding of formulation design, manufacturing process development, absorption science, and performance-based drug product development.
• Knowledge and application of amorphous drug product manufacturing processes, formulation design, stability evaluation,
• Experience with technical approaches such as predictive modeling, dissolution and permeability studies, advanced DoE designs, and experimental strategies that support biopharmaceutic understanding, formulation, and process development.
• Familiarity with CMC documentation and GxP environments, including GMP and GLP expectations.
• Ability to work across functions, solve scientific problems, communicate clearly, and contribute to multidisciplinary teams.
• Strong scientific writing, presentation, collaboration, and mentoring skills are an advantage.

Commitment to Diversity and Inclusion : Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to E-Mail auf novartis.com ansehen and let us know the nature of your request and your 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 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?

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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