Senior Manufacturing Operations Manager

1 week ago


Piscataway New Jersey, United States Global Life Science Hub Full time
Position Overview:
Global Life Science Hub is pleased to announce an opportunity for a Senior Manufacturing Operations Manager to join a prestigious pharmaceutical manufacturing organization.

About the Company:
This leading company is recognized for its dedication to innovation and excellence in the development of pharmaceutical dosage forms.

Key Responsibilities:
  • Oversee the development of pharmaceutical dosage forms.
  • Conduct thorough analysis of dosages in the manufacturing process.
  • Ensure the monitoring and implementation of commercial, validation, and ANDA batches.
  • Lead qualification processes including IQ, OQ, and PQ.
  • Review and prepare ANDA documentation.

About Us:
The Global Life Science Hub specializes in connecting top-tier talent with opportunities in the life sciences and pharmaceutical sectors across Europe and the US.

Qualifications:
  • Bachelor's degree (or foreign equivalent) in Pharmaceutical Science, Pharmacy, Chemistry, or a related discipline.
  • At least 5 years of progressive experience in:
    • ANDA (Abbreviated New Drug Application)
    • IQ (Installation Qualification)
    • OQ (Operational Qualification)
    • PQ (Performance Qualification) validation
    • SOP (Standard Operating Procedure) development
    • Scale-up and technology transfer
    • cGMP (current Good Manufacturing Practices)


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