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Product Development Manager

Job description

Product Development Manager

 

Job Purpose: Manage all formulation/process development activities, clinical/registration programmes related to new product development

  • Manage all new products either being developed in the company or transferring from other companies or clients, supporting and preparing NDA submissions
  • Developing and performing experimental programmes to support new product development and implementation

  • Managing the on-going development to existing and new products

  • Technical lead in the evaluation of new and existing technologies

  • Preparation and management of budgets pertaining to new projects.

  • Managing the Oral Solid Dosage Development Area (Area D) and all operations within this facility.

  • The Person/Requirements

    The successful applicant must possess the following knowledge, skills, qualifications and experience.

  • A PhD in a life science (Chemistry)

  • At least 8 years’ experience working within an FDA/HPRA approved Oral Solid Dosage/New Product Development
    function.

  • Experience of preparing CMC regulatory submission (E.G. NDA or EMA submissions).

  • Experience of applying good development practices/ QbD methodology to process development.

  • Demonstratable experience of managing a team.

  • Ability to troubleshoot and identify technical issues and follow up with corrective actions.

  • Ideally the successful candidates will have worked with high containment compounds

If you would like to apply for this senior level job please contact Clara on 01 4744676 or email chenry@sigmar.ie

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