Description
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