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Manager of Inhalation and Research Development

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Coda Search│Staffing

2021-12-03 07:45:22

Job location Dayton, New Jersey, United States

Job type: fulltime

Job industry: HR / Recruitment

Job description

Job Overview


The Manager or Director will lead a team developing generic metered dose inhalers (MDIs). Responsibilities include reverse engineering, device and formulation development, process development and scale-up, and generation of documents for regulatory filings.


Responsibilities

Lead a team of 4+ scientists and engineers

  • Develop generic MDIs
  • Reverse engineering of marketed products
  • Formulation and device development
  • Process development and optimization (pilot to exhibit scale)
  • Preparation of documentation for ANDA filing
  • Contribute to a cross-functional team to meet scientific, quality, and regulatory requirements for ANDA filing


Qualifications - Skills & Requirements:

  • MDI formulation and process
  • Statistical design of experiments
  • Fine particle generation and characterization
  • Aerosol testing
  • Regulatory knowledge of the MDI space (e.g. Guidance Document familiarity)
  • Team leadership
  • Written and oral communication skills
  • Timeline and organizational skills
  • Other Duties as assigned


Education & Experience:

  • Manager (2+ years) or Director (5+ years)
  • PhD preferred (chemistry, pharmaceutical science, chemical engineering, or related field)
  • Experience in MDI product development

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