Principal Engineer/ Scientist


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https://www.teamhorizon.ie/1168-principal-engineer/scientist/laboratory/scientific/dublin/job2024-02-22 13:55:011970-01-01Team Horizon
Job TypePermanent
AreaDublin, IrelandDublinIreland
SectorLaboratory/ScientificOperations & Manufacturing
Start Date
AdvertiserMary King
Job Ref1003175
Job Views293
Description
Team Horizon is seeking a Principal Engineer/ Scientist Device Portfolio and Business Development for our client based in Dublin.

 

 

Why you should apply:



  • Join a company who are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.


  • Be part of a diverse, inclusive and authentic workplace that offer competitive salaries, benefits & career progression opportunities


 

 

What you will be doing:



  • Support due diligence of the device element of combination products identified as opportunities to expand the Global portfolio through acquisition or licensing opportunities with external stakeholders


  • Support the global portfolio review process which assesses new product opportunities for the global pipeline by identifying development timeline, costs and any associated risk or challenges.


  • Develop detailed budget forecast for development of new combination products including design, manufacture, assembly and testing to support portfolio review board assessment


  • Build intelligence on device landscape for injectable, inhalation, dermatology, and ophthalmology combination products


  • Support device program teams in building program strategy by providing information on business plan, competitor intelligence, launch strategy, suppliers/ partners


  • Identify and build contacts with potential new device suppliers


  • Research and present business and technical information on new combination products supporting due diligence, portfolio review and early program strategy.


 

What you need to apply:



  • The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment.


  • Masters/Degree in Engineering/Science with min 5 years’ experience in R&D environment is required.


  • Previous experience of working as an Engineer or Scientist role in a regulated and GMP environment on combination products is required.


  • Knowledge of the device landscape for injectable and respiratory devices including detailed understanding of device design, functionality, molding and assembly processes is desirable.


  • Knowledge and previous experience of compiling and preparing regulatory submissions for US/EU/ROW including ability to review submissions is desirable.


  • A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.


  • Ability to review complex data and regulatory packages and identify business risks is required.


  • Experience in data analytics including reviewing market trends and forecasts and experience of using IQVIA database is desirable.


  • Experience of preparing and managing large budgets accurately formal business qualification is desirable.


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