Biotechnology Process Manager

5 days ago


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

**Job Summary:**

The Manufacturing Manager, Upstream is responsible for overseeing the planning, direction, and coordination of activities related to Upstream manufacturing processes while maintaining highly effective operations leading to the production of safe and compliant therapeutics.

This role involves overseeing cGMP production and Upstream manufacturing systems working directly with cell culture and viral propagation techniques, cell culture and bioreactor operations, bacterial and fermentation operations, pDNA, protein, and yeast-related operations, and aseptic techniques following cGMP procedures.

**Key Responsibilities:*

  • Oversight of Upstream manufacturing operations including planning, directing, and coordinating activities to ensure timely delivery and right-first-time execution of manufacturing operations.
  • Maintenance of Upstream processes at the highest level of cGMP compliance per FDA and customer expectations.
  • Budgeting and resource allocation for Upstream manufacturing operations.
  • Leadership and development of Upstream manufacturing staff to achieve productivity targets and output requirements.

**Requirements:*

  • Master's degree in Science, Engineering, or other related field and four (4) years of relevant experience including four (4) years of supervisory/management experience; OR
  • Bachelor's degree in Science, Engineering, or other related field and six (6) years of relevant experience including four (4) years of supervisory/management experience; OR
  • Associate degree in Science, Engineering, or other related field and eight (8) years of relevant experience including four (4) years of supervisory/management experience; OR
  • High school/GED in a related field and ten (10) years of relevant experience including four (4) years of supervisory/management experience.


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