Operations Program Manager

5 days ago

Bend, Oregon, United States Rezolute, Inc. Full time
Job Summary

We are seeking a highly motivated and experienced Operations Program Manager to join our team at Rezolute, Inc. The successful candidate will be responsible for ensuring the close internal and external coordination of drug manufacturing programs in our portfolio.

Key Responsibilities
  • Program Management: Provide day-to-day management of ongoing manufacturing tasks with internal stakeholders (MSAT, QC, and QA) and external vendors.
  • Supply Chain Management: Track and manage the integrated Global Supply plans and timelines, ensuring deliverables and activities are aligned across all functions, and confirming dependencies feed into the integrated master project plan and timeline.
  • Project Coordination: Generate program-related Gantt charts and Dashboards, effectively manage team meetings, and institute cross-functional program/project teams.
  • Contract Management: Review CDMO contracts for completeness and generate Purchase Orders for approval.
  • Financial Management: Aid in the management of the manufacturing project financial management system, working with the Senior Director – Supply Operations, Senior Manager - Global Supply Planning, and Rezolute Finance department.
  • Documentation Management: Help manage Documentation Management for Pharmaceutical, Analytical, Formulation Process Development, and corresponding cGMP activities, partnering with Rezolute MSAT SME's, Quality teams, and external vendors.
  • Quality Assurance: Support SME's with GMP documents, including change controls, deviations, and standard operating procedures, and partner daily with Quality Assurance to ensure compliance with cGMP regulations and Rezolute Quality Systems.
Requirements
  • Education: Minimum Bachelors' degree in scientific/technical discipline.
  • Experience: Minimum 5 years total relevant experience (including industry, project management, or private/government institution).
  • Skills: Understanding of biotech, cGMP requirements for Upstream and Downstream Biologics Drug Substance development/manufacturing, and/or Aseptic Drug product development/manufacturing.
  • Personal Qualities: Action-oriented with strong follow-through, strong attention to detail, and ability to effectively manage work performed by staff working remotely.
Preferred Qualifications
  • Previous Experience: Previous management experience with a biologics-based clinical phase biopharmaceutical company or with a biologics CDMO.

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