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Product Development Specialist

Pharmaceutical

Surrey £45k – £55k
permanent Job Ref: 6487

Description

A growing pharmaceutical company has an exciting opportunity for a Product Development Specialist to join its team.  Your role will be to take day-to-day responsibility for managing product development projects from concept to commercialisation including management of contract development and manufacturing partners. You must have previous experience in working in a pharmaceutical production or development environment and have proven project management experience.

Responsibilities:

  • Work in collaboration with internal stakeholders to identify and design technically viable and pragmatic product development opportunities (both unlicensed and licensed products).
  • Identify and recommend the best contract development and manufacturing partner for each project.
  • Plan and cost out projects and ensure that realistic and credible project plans are constructed and maintained as live working tools.
  • Identify the appropriate resources (financial expertise equipment) required for each project and ensure that these are allocated within the company and the contract development and manufacturing partner.
  • Manage actively the development project including the activities being undertaken by the external partner companies.
  • Ensure that projects are conducted in a transparent manner and that legitimate stakeholders receive updates and communications in a timely manner.
  • Work with contract manufacturers and colleagues to identify and implement robust and optimised solutions to product supply related problems as they arise.
  • Managing analytical and technical transfer of products to a new site(s) of manufacture.
  • Identify new sources of materials and new sites of manufacture to agreed timelines (as required) and costs.
  • Develop the technical and clinical data of selected product to CTD standard to support MAA.
  • Ensure documentation is completed in required time
  • Clear communication to internal company stakeholders on the progress and costs of technical projects
  • Travel to and spend time as required at supplier contract manufacturer or other potential partner sites.

Experience Required:

  • Prior experience of working in a pharmaceutical production or development environment to include working with staff on issues arising within a production environment.
  • Familiar with the concepts of GxP systems and other pharmaceutical terms and acronyms.
  • Experience of managing product development transfer and of product change projects including planning documentation cost control and communication.
  • Ability to establish and maintain effective working relationships with internal and external stakeholders.
  • Strong written and verbal communication skills including the ability to put forward a coherent and compelling case taking the needs of other stakeholders into consideration.
  • Preferably experience in writing / reviewing of IMPD’s/MAA’s.
  • BSc or equivalent science based degree.

£45k- £55k + Benefits

Job Ref: 6487