Formulation Development Manager

4 weeks ago


Fort Lauderdale, Florida, United States Transpire Bio Full time
Job Summary

We are seeking a highly skilled Formulation Development Manager to join our team at Transpire Bio. As a key member of our research and development team, you will be responsible for leading the development and evaluation of new formulation technologies for solid formulations, including conventional and engineered dry powder inhalers (DPIs).

Key Responsibilities
  • Conduct, lead, and supervise standard and advanced laboratory activities for the development of solids formulations, including DPIs, following regulatory guidelines, industry best practices, and US FDA cGMPs.
  • Design and lead pre-formulation, formulation, and process development studies to recommend the selection of APIs, excipients, packaging material, and manufacturing processes.
  • Develop and evaluate new formulation technologies, including DPIs, and possess a strong understanding of experimental design.
  • Provide expert support for manufacturing-related technical issues and write protocols, reports, methods, and standard operating procedures.
  • Develop statistical design of experiments with minimal supervision and participate in project activities to support project timelines and team objectives.
Requirements
  • Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Material Sciences, Chemistry, Chemical Engineering, or a related discipline with 6-12 years of research experience in the pharmaceutical or related field.
  • Expert knowledge of development and manufacturing of solid formulations, including DPIs, and global regulatory requirements as applied to orally inhaled and nasal products (OINDPs).
  • Strong English language skills, including writing ability and oral communication, and experience with writing chemistry, manufacturing, and control (CMC) sections of US and EU regulatory documents.


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