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.
- 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.
- 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