Principal Engineer/ Scientist
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Job Type | Permanent |
Area | Dublin, Ireland |
Sector | Laboratory/ScientificOperations & Manufacturing |
Start Date | |
Advertiser | Mary King |
Job Ref | 1003175 |
Job Views | 293 |
- 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.