Job Title: Inhalation Group Leader / Manager / Sr Manager

Company: Aurobindo Pharma USA (North Carolina facility)

Description

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.

Requirements

  • 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.

Contact: jholt@AurobindoUSA.com