Manager, Product Development

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

Job Description:

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

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