CMC Technical Integrator
Pharmaceutical company specialized in the development of vaccines. You will represent the Analytical Development Department on the CMC team.
Do you have extensive analytical development experience in the pharmaceutical industry and do you have excellent project management skills? Then this position might be interesting for you! As a CMC Technical Integrator you will ensure the technical representation of the line organization of the Analytical Development Department in CMC (Chemistry, Manufacturing & Controls) project teams.
As a CMC Technical Integrator you will ensure the technical representation of the line organization in CMC project teams
- You will coordinate the project deliverables in close collaboration with the CMC Team Lead and functional line management.
- You maximize the generation and use of knowledge to not only support project objectives but also grow departmental functional expertise. (re-useable knowhow)
- Responsible for functional budget alignment
- You will lead a functional sub-team containing other functional reps and Subject Matter Experts(SME) and are responsible for the planning and executing of functional project deliverables in close collaboration with the line to the desired cost and quality level
- Responsible for successful functional process technology transfer to the plant/CMO includingprocess-fit-to-plant activities
For the position of a CMC Technical Integrator we are looking for an enthusiastic and communicative candidate.
- 8+ years pharmaceutical industry experience preferably in a biopharmaceutical drug development environment and/or manufacturing environment
- Project management experience (2-3 yrs)
- GMP and regulatory process experience is required
- Experience in Analytical Development and in particular in analytical method development and validation, interaction with regulatory agencies (IND/IMPD, MAA/BLA, briefing documents, etc) and ICH stability studies
- Knowledge of other CMC activities (Drug substance/Drug product)
- Ability to lead multidisciplinary teams of professionals and foster team productivity in a matrix environment
- Proven organizational sensitivity and conflict resolution and planning skills
- Secondment via Checkmark Labrecruitment for 1 year. Longer term anticipated
- Salary indication from €4500,- to €6500,- based on fulltime
- Fulltime position (40 hours/week), 32 hours discussable
- Ability to work on site at least 3 days oer week
Neem voor meer informatie contact op met Jurjen Wilschut: 0182 590 212 // 06 3024 7453
Fulltime / parttime