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Manufacturing Operations Manager

1 week ago

Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

Job Responsibilities

The Manufacturing Supervisor will be responsible for supervising a team of employees directly or indirectly in production process units. The individual will oversee daily manufacturing activities, including the operation of single-use cell culture vessels, bacterial fermentation culture vessels, alpha Wasserman continuous flow centrifuges, disposable magnetic mixing bags and totes, cell expansion and propagation, banking/cryopreservation of cell lines and viruses, hyperstack, cellstack, and other adherent cell technologies.

Key Performance Indicators

  • Ensures compliance with cGMP regulations and company policies.
  • Responsible for implementing project safety and quality assurance programs.
  • Develops, writes, and reviews Standard Operating Procedures, Buffer Formulation Records, and Batch Production Records (BPRs).
  • Ensures proper documentation and execution of BPRs and activity records.
  • Leads deviation resolution and closure with subject matter expert and quality teams.

Requirements

  • Demonstrated leadership, coaching, and mentoring skills.
  • Demonstrated experience in training others to perform and maintain cGMP standards.
  • Excellent skills with Microsoft Office applications.