Formulation Project Leader (Early Phase)

Novartis Pharma Schweiz AG seeks a Senior Formulation Project Leader for early-phase oral drug development in Basel. The role focuses on guiding formulation strategies, biopharmaceutic expertise, and cross-functional collaboration for small-molecule programs.

The company is looking for a senior professional to lead formulation project activities and provide biopharmaceutic expertise for innovative oral drug development programs. This position involves guiding manufacturing and formulation efforts for small-molecule oral dosage forms while analyzing how molecular properties and process parameters impact drug absorption and in vivo performance. The role also supports the creation of data-driven strategies that facilitate development from initial human studies through scale-up and regulatory submission.

Responsibilities

• Oversee formulation development and manufacturing processes for oral dosage forms, covering early clinical phases through final process definition for Phase 3 and later stages.
• Create and manage comprehensive project plans that align formulation, control strategies, biopharmaceutic assessments, and supply activities with broader program goals.
• Offer scientific expertise regarding the connection between drug substance characteristics, dosage form design, dissolution, permeability, and in vivo performance.
• Plan, analyze, and combine in vitro, in silico, and in vivo biopharmaceutic studies to inform formulation selection and development choices.
• Act as a core member of cross-functional drug product teams, working closely with Pharmaceutical Development, Chemistry & Analytical Development, PK Sciences, Translational Medicine, and technical operations.
• Assist in preparing scientific documentation and CMC/development dossiers, including addressing health authority inquiries and supporting regulatory inspections.
• Utilize innovative techniques like predictive modeling, biorelevant testing, quality-by-design principles, and digital methods to advance formulation and biopharmaceutic development.
• Mentor colleagues, share knowledge, and enhance scientific capabilities across teams.

Requirements

• Advanced degree in Pharmaceutical Sciences, Pharmaceutical Technology, Chemical Engineering, Chemistry, or a related field; a PhD or equivalent experience is preferred.
• Industry experience in formulation development and/or biopharmaceutics within pharmaceutical development, preferably for small-molecule oral dosage forms.
• Comprehensive knowledge of formulation design, manufacturing process development, absorption science, and performance-based drug product development.
• Understanding and application of amorphous drug product manufacturing processes, formulation design, and stability evaluation.
• Experience with technical approaches such as predictive modeling, dissolution and permeability studies, advanced DoE designs, and experimental strategies to support biopharmaceutic understanding 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.

Nice to have

• Strong scientific writing, presentation, collaboration, and mentoring skills are an advantage.

About the company

The company values a collaborative and scientifically strong professional environment.

• Emphasis on collaboration and scientific excellence.