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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Director Combination Product Development


Reference:JCAO2232 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Our client a global Healthcare with their Global R&D group based in Ireland are currently seeking a Director, Combination Product Development


Role/Responsibilities:

  • People manager of Scientists and Engineers who support device development for Biological, Respiratory and Transdermal combination products.
  • Build and expand team with responsibility for hiring new positions to support new technologies and programs within the Biologics, Respiratory and Transdermal portfolio.
  • Lead a team who support device development by robust characterization of combination products and collaboration with the drug product and commercial manufacturing teams to support regulatory submissions and product approvals.
  • Responsible for technical interface between drug product and device teams during combination product development on elements such as primary container interface and compatibility, exhibit batch manufacture and stability studies
  • Lead and provide technical oversight to a team responsible for design verification, stability, biological evaluation, extractables, and transport & shipping studies.
  • Responsible for leading a technical team during regulatory and notified body inspections by representing the team in front of auditors and ensuring audit readiness.
  • Overall responsible for method development, approval of method validations and test protocols and reports.
  • Technical oversight of team responsible for the development of design requirements and combination product specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
  • Responsible for oversight and management of all testing activities outsourced to contract laboratories and set up of new vendors to support evolving technical requirements.
  • Provide technical support to manufacturing sites during filling and assembly process development. Responsible for designing experiments and manufacturing trials to identify process controls, reliability requirements, sampling plans and release specifications.
  • Responsible for ensuring a device control strategy is in place to support combination product manufacture and transfer to manufacturing site.
  • Trending and statistical analysis of design verification 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 Quality Management System.



Skills/Experience



  • The ideal candidate will be a qualified, highly 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 experience in R&D or Technical Support environment.
  • Previous experience of managing a technical team in an R&D environment.
  • Experienced in writing regulatory submissions.
  • Experienced in leading a technical team in support of FDA, HPRA or notified body inspections
  • A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
  • It is essential that the candidate will be both highly innovative and well organized, 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 information to key stakeholders.
  • Some travel will be required as part of this role.


For further information please contact James Cassidy [email protected] or call in confidence 0860204322