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Manager, Product Development

Company: Germer International
Location: Paramus
Posted on: May 25, 2023

Job Description:

Essentially generate all the data and issue development report for new products

  • Responsible for all aspects of product development
  • Perform Preformulation and formulation studies to finalize generic formulation for filing
  • Perform QTTP, QBD, Compatibility DOE, Process Ranging
  • Identify Materials, sources, specifications
  • Issue Change controls and documentation to establish new materials into site systems
  • Project manage all in house and external analytical development work
  • Facilitate all product characterization testing and reporting for in house and external testing
  • Create development and submission batch records, protocols and data summaries
  • Facilitate all RLD/RS comparability testing
  • Generate all data and prepare the Product Development report to support ANDA filing
  • Support clinical studies with necessary information
  • Assess stability trends

    • Lead, coach and motivate development team
    • Complete other duties and tasks as assigned


      • Prefer 5 years experience in solid oral manufacturing/packaging in the pharmaceutical industry;
      • Bachelors Degree Required
      • Masters Degree Preferred
      • Demonstrated ability to handle multiple projects
      • Proficient in Word Excel MS Project
      • Communication and interpersonal skills.

        • Flexible work hours and schedules
        • Strong problem solving and analysis skill
        • Attention to details and a strong focus on quality and safety
        • Ability to coach, mentor and train employees

Keywords: Germer International, Paterson , Manager, Product Development, Executive , Paramus, New Jersey

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