Description
The role leads drug product technical development activities for late-phase oral drug product programs, ensuring scientific excellence and alignment with project objectives.
Tasks
- Represent drug product project teams within development sub-teams, providing technical leadership
- Develop robust drug product project strategies including risk assessments and contingency planning
- Assess, consolidate and negotiate project resources, timelines and costs, leading the budgeting process
- Ensure adherence to project review processes and relevant governance boards
- Manage cross-functional project interactions and oversee high-quality development documentation for submissions
- Apply science-based approaches such as quality-by-design and modelling to support development decisions
- Lead, coach and support project teams, fostering collaboration and high performance
Profile
- Advanced degree in Pharmaceutical Technology, Powder Process Engineering or a related scientific field
- PhD or equivalent experience valued
- Minimum 5+ years of relevant industry experience in pharmaceutical formulation development
- Solid understanding of Quality by Design (QbD) and regulatory guidelines (ICH Q8, Q9, Q10)
- Strong knowledge of relevant GLP and GMP regulations and policies
- Excellent leadership, scientific, project management and presentation skills
Offer
- Onsite role in Basel
- Flexible and hybrid working options where possible
Company
Pharmaceutical development