Reference Code
DU1887

We are seeking an experienced Subject Matter Expert in the area of Biologics Active Pharmaceutical Ingredient (API) Production to join the global technology team

The role is to work as a Subject Matter Expert providing technical leadership on biologic API projects.  As a part of the global technology team the person employed can be located in one of the PM Group offices in US, Europe or Asia, or possibly can work remotely from their home location with travel to project meetings/workshops as required.

 

Responsibilities

  • Manage and produce/check the project early stage process deliverables required for a biologics API facility which includes scoping and philosophy documents, mass balances, bioprocess simulation models, process flow diagrams, and P&ID’s
  • With excellent presentation skills it will be required to interface with clients and facilitate workshops
  • Technically assist project teams particularly in the early project phases such as Site Master Planning, Feasibility and Concept Studies, as well as Basic Design
  • Engage with an existing global network of Subject Matter Experts and assist in the training and mentoring of next generation of Subject Matter Experts in the company
  • Have the ability to distil down problems to their essence, demonstrate problem solving skills and have a talent to innovate

 

Qualifications & Requirements

  • 20 years+ experience in design and/or operations and/or process development of biologic API systems and facilities is essential
  • A history of wider industry engagement with institutions such as the ISPE and an awareness of key industry technology initiatives and direction would be ideal
  • Excellent knowledge with upstream and/or downstream operations and support functions, as well as familiarity of equipment options available and the selection criteria as to when such options should be chosen is desirable
  • A good understanding of the principles of layout of a facility to accommodate a biologic API facility and how to achieve the operation with the HVAC grades associated with the required process steps
  • A good understanding of both stainless steel and single-use systems
  • Good appreciation of GMP Regulatory framework for implementation of biologic API projects

 

Please Note

All CV’s are treated in the strictest confidence.
Recruitment agencies need not apply.

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Biologics API Subject Matter Expert DU1887 - DU1887

Dublin, Ireland

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