Formulation Project Leader (Early Phase)

Job Description Summary

Job Description

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 Youll 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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired