Principal Scientist
18 hours ago
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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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