Beschreibung

The role develops robust manufacturing processes for parenteral drug products, from process characterization to technology transfer and commercial launch.

Tasks

• Develop manufacturing processes for parenteral liquid and lyophilized formulations
• Design and execute process characterization and process design studies
• Lead technology transfer projects to global commercial manufacturing sites
• Represent process development in cross-functional and international project teams
• Collaborate with manufacturing sites to ensure successful project execution
• Author sections of regulatory submissions for Phase 1-3 and marketing applications

Profile

• PhD or master's degree in chemistry, chemical or process engineering, or related field
• Minimum 5 years of industry experience in drug product process development
• Expertise in parenteral process development and technology transfer to commercial sites
• Experience designing and justifying down-scale models and process parameters
• Track record of parenteral drug product launches for synthetic molecules
• Experience authoring drug product sections of regulatory submissions (NDA/BLA)
• Willingness to travel internationally up to 20 percent

Offer

• 3–6 months interim, then a permanent position

Company

Pharmaceutical development