Beschreibung
The role leads formulation and manufacturing process development for oral solid dosage forms across late-phase drug product development programs.
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
Profile
- 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 transfer
- Experience 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
Offer
- Onsite role in Basel
- 3–6 months interim, then a permanent position
Company
Pharmaceutical development