Associate Director, R&D
Associate Director, R&D is expected to be the technical lead for all projects and have a good understanding of science in the assigned therapeutic area and a good understanding of the manufacturing requirements for the new product.
- Associate Director, R&D will manage a group of transfer leads at the receiving site with responsibility for technology transfer activities from R&D to the MS&T site level.
- He/she will lead technical transfer project lead team at the site and liaise efficiently and effectively with involved functions (e.g. Development, Chemistry, Supply Chain, Production Unit, Quality Control, HSE, other ).
- Instigates new projects which lead to site enhancements, research potential novel products and process improvement for implementation into
- The Associate Director, R&D needs to have a solid sense of
Project Management Responsibilities
- Provide project leadership and have responsibility for all deliverables within an assigned project. This includes leading the project team in alignment with the strategy approved by Development or Therapeutic heads. This also includes leading the planning process for the project. Provide project specific technical and scientific leadership to the project
- Assessing technical risks & resolving issues
- Assessing schedule risks & identifying acceleration opportunities
- Responsible for planning activities within the core team
- Responsible for management of communications at all levels of organization (operators, sub-team, PRM, PMC, MTO, QA)
- Owner of Manufacturing Process Transfer Plan
- Support Development or Therapeutic Heads in interactions with MTO and QA to ensure smooth product transfer to manufacturing
- Ensure all functions supporting the project team are adequately resourced. Elevate issues to Project Heads/RDLT.
- Accountable for developing realistic project budget forecasts in collaboration with Project Head and Project Manager
- Based on Complexity of project or based on where project is in development timelines, Project Manager can be responsible for 1, 2 or more
- Ability to manage complex
Preferred Position Knowledge/Skills/Abilities:
Knowledge and experience of optics and optical metrology Knowledge and experience of machine and automation design. Knowledge of statistical process control.
Knowledge of validation requirements, equipment, process, computer systems, GAMP5.
Knowledge of Irish government funding mechanisms available to support R&D projects
Minimum: Bachelor's degree in engineering/ Physics or related discipline
Preferred: Masters/ PhD degree in. Engineering/ Physics or related discipline
Minimum: 5-8 years' experience in an advanced technical role which can include applied post graduate studies
Preferred: 5-10 years' experience in an R&D / NPI role executing product and process technology transfers in a regulated industry environment
Project management and team leadership experience.
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