Formulation Project Leader

The role leads formulation and manufacturing process development for oral solid dosage forms across late-phase drug product development programs.

Your tasks

• Lead formulation development and manufacturing activities for oral dosage forms across development phases
• Develop and maintain project plans aligning formulation, manufacturing and supply with program timelines
• Apply quality-by-design, modelling and digital tools to support development decisions
• Collaborate with pharmaceutical development, analytical development, technical operations and QA teams
• Own technical documentation including development reports, manufacturing instructions and CMC documentation
• Support responses to health authority questions and regulatory inspections
• Handle change requests and deviations in quality systems as initiator and owner

What you bring

• Advanced degree in Pharmaceutical Technology, Powder Process Engineering or related scientific field
• PhD or equivalent experience valued
• Minimum 5+ years of experience in solid formulation and/or process development
• Understanding of formulation design, manufacturing process development, scale-up and process transferExperience applying structured data-driven approaches such as modelling, PAT, DoE or statistical analysis
• In-depth knowledge of CMC documentation and GxP environments including GMP and GLP

Conditions

• Workload: 100 %
• Work model: On site
• Option of a permanent position after the assignment if both sides want it

What to expect

• Onsite role in Basel
• 3-6 months interim, then a permanent position

Technologies

• PAT
• DoE