Job Title: Inhalation Group Leader / Manager / Sr Manager
Company: Aurobindo Pharma USA (North Carolina facility)
The successful candidate will lead a team of scientists in the development of metered dose inhaler (MDI) products at its new R&D center in RTP, North Carolina.
- Responsible for reverse engineering, pre-formulation, formulation development, selection of raw materials and devices, aerosol performance testing, and stability studies.
- Design and oversee late-stage product characterization studies.
- Provide expert guidance for scientific investigations and troubleshooting.
- Prepare scientific reports, including those for regulatory submission.
- Coach and develop junior staff.
- Maintain a safe and compliant work environment.
- Masters or Ph.D. in chemistry, pharmaceutical sciences, or related field.
- At least 5 years of relevant experience in a pharmaceutical environment.
- Strong knowledge of metered dose inhaler product development, including formulation, testing, and regulatory requirements.
- Excellent team leadership, project management, and oral and written communication skills.
- Expertise in developing and conducting methods for cascade impaction (e.g. ACI & NGI), dose content uniformity, Karl Fischer moisture analysis, micronization (jet milling), particle size by laser diffraction, spray pattern, and plume geometry.
- Strong working knowledge of statistical design of experiments (DoE), Quality by Design (QbD), and the preparation of reports for the CMC section of regulatory documents.