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Consultant in PMO

  1. United States
Raleigh
  1. Contract
Competitive
  1. Life Sciences
22-03-2024
33432
Consultant in PMO - Raleigh, North Carolina - 15-Month Contract 

Our client, a global Pharmaceutical manufacturing organization are looking for a talented Consultant in PMO to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Responsibilities: 

Drive the identification, prevention, and remediation of risks to cGMP operations readiness for a greenfield large scale Biopharmaceutical facility focused on the manufacture of monoclonal antibody drug substance and drug product. This includes responsibility for the following areas in partnership with both full-time employees and other consultants on the project:
  • Project management plans and delivery for the risk management portion of the larger operations readiness project.
  • Communication plans regarding risk management for operations readiness.
  • Drive prospective weekly gemba and deep dive for key milestone objectives within the operations readiness plans.
  • Drive response and action plans to significant issues impacting the delivery of on-time high-quality cGMP operations readiness for the facility.


Requirements: 

Experience and contacts;
  • Proven experience in biopharmaceutical cell culture, purification, and fill finish facility operations. This would also include experience with support areas within the facility such as laboratories, warehouse, maintenance, utilities etc.
  • Proven experience delivering cGMP operations readiness for a greenfield drug substance and drug product cell culture facility.
  • Proven experience driving prospective and reactive processes for risk identification, prevention, and remediation.
Knowledge and Skill;
  • Mature skills leading cross functional teams and providing project management, communications (oral, written, and powerpoint), risk management and gemba consulting services.
  • Subject matter expert for cGMP and operations expectations to start up a new greenfield biopharmaceutical cell culture manufacturing site that has drug substance, drug product and all support operations on site.
  • Natural positive attitude and ways of working to inspire the best in team performance. This must be paired with ability to find and call out gaps and risks in team plans and performance. We need a person to come in and challenge teams to continuously improve plans and delivery.
 

If this role is of interest to you, please apply now! 

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