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Principal Consultant recruiting for the Life Sciences Industry
Here, in Hays Recruitment, our Pharmaceutical client in Dublin is hiring a Principal Scientist.
Your new role
* Provision of subject matter expertise to support the development of Combination Products.
* Leading a team to plan and execute design verification and reliability strategies.
* Responsible for technical interface between drug product and device teams during combination product development, ensuring formulation and manufacturing development activities are compatible and align with device development.
* Responsible for the development of design requirements and specifications based on characterisation of comparator products, regulatory requirements, design intent and user requirements.
* Responsible for developing test methods and specifications to assess device functionality and product performance, implementing evaluation, procurement & implementing new, state-of-the-art lab testing equipment as applicable.
* Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification.
What you'll need to succeed
* Degree in Science/Engineering (Master’s preferred).
* 7+ years’ experience in pharmaceutical and/or medical device development.
* Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.
* Experience in the development and validation of analytical methods.
* Experienced in application of statistical techniques for data analysis.
* Experience of writing and supporting regulatory submissions.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Design, Product Management, and Quality Assurance
Industries
Pharmaceutical Manufacturing
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