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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Principal Material Scientist


Reference:JC1010 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Material Analyst, Materials Scientist

Principal Material Scientist




Our client a global healthcare company are currently seeking a Principal Materials Science to join their team. The Principal Material Scientist will act as a subject matter expert for a Global Devices Group



Role/Responsibilities

  • Subject matter expert on device materials including material characterisation, biological evaluation, extractable profiling and packaging studies across biological , injectable, respiratory and Dermatology products.
  • Material selection for device materials and packaging to enable device functionality, ensure compatibility with drug product and meet safety and efficacy requirements for the combination product.
  • Development of material requirements and specifications for devices ensuring compliance with the required regulatory requirements for combination products
  • Responsible for performing biological evaluation of medical devices following a risk-based approach in line with IS0 10993-1. Oversight of biocompatibility testing and working with toxicology group to interpret results as required.
  • Responsible for performing material characterization including physiochemical testing, accelerated aging studies , in-depth literature review , extractable and elemental analysis
  • Responsible for ensuring extractable profiling studies are completed on device components, setting of specifications for development through to routine commercial production and linking of extractables to leachables
  • Author of Drug Master File for drug components and review of suppliers DMF to support device control strategy
  • Develop and lead device stability studies to underwrite device shelf life
  • Physical and Chemical Characterisation of plastic packaging and materials of construction as per relevant USP and Ph.Eur chapters
  • Periodic review of relevant PhEur and USP Pharmacopeia’s, EMEA and FDA guidance’s and ISO standards to ensure compliance with latest regulatory guidance and industry trends
  • Build testing capability to perform material characterisation to support product development by identifying external testing laboratories and develop connections with Universities and industry experts
  • Responsible for compilation and review/approval of technical documentation within GDD in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking.
  • Lead robust analytical method development and validation including transfer of methods to commercial sites as required
  • Trending and statistical analysis of analytical and manufacturing data including compilation of technical reports to support combination product development lifecycle.
  • Ensures all activities within team are conducted and executed to the appropriate quality standards within the group


Skills /Experience
  • 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 Science with significant experience in a late stage R&D or Technical Support environment
  • Previous experience of working as a Scientist role in a regulated and GMP environment on combination products i.e. injectable or respiratory products
  • Expertise in material characterization including biological evaluation , biocompatibility and extractable studies is required
  • Previous experience in compiling analytical sections of regulatory submissions and DMFs is desirable
  • Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role
  • It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams. In addition, the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.
  • Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders
  • Some travel will be required as part of this role