- The duties and responsibilities of the Product Development Manager will primarily involve but are not limited to the following:
- The Product Development Manager will work with HHC to 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 including the carrying out of analysis in house or organising external.
- Managing the on-going development to existing and new products which optimise efficiencies and also provide innovative solutions to client requirements.
- The Product Development Manager will be the technical lead in the evaluation of new and existing technologies and identifying product types which may be of preparation and management of budgets pertaining to new projects.
- Managing the Oral Solid Dosage Development Area and all operations within this facility.
- PhD in a life science with 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.
- Passed experience of managing a team.
- Ability to troubleshoot and identify technical issues and follow up with corrective actions.
- Ability to work well with all key contacts both internal and external to the organisation.
- The candidate will need to display clear and effective communication skills and have a focus on the development of teams.
- Ideally the successful candidates will have worked with high containment compounds and/or with experience of parenteral manufacturing.
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