Do you have experience with CMC development and excellent project management skills? Within this position you will plan and manage cross-functional project deliverables that support the CMC development and Commercial Launch. Are you curious to find out more about this position. Then, keep reading!
As a CMC Project Manager you will translate the CMC strategy into realistic and executable CMC deliverables with clear assumptions based on CMC & Commercial input. Key responsibilities:
- Provide CMC Team Support and represent the CMC Program Manager at the Program Management Team (PMT)
- Support risk management process, specifically identification and development of mitigation strategies with CMC team & PMT
- Work out scenarios to support decision making in line with CMC, JSC and CDT strategy
- Manage the CMC end-to-end process from pre-NME through launch
- Work in close collaboration with the CMC Leader, SI’s, JSC New Product Team (NPT) and Commercial Lead as well as the CDT Program Management Leader (CDT-PML) to ensure alignment of the CMC strategy with the CDT strategy
- Proactively identify areas of need within the department
- Outline new processes and support the integratration of enabling technologies into the team setting to drive efficiency
For the position of CMC Project Manager we are looking for a PhD who has experience with CMC development. You have:
- A PhD degree in a pharmaceutical-related and 8-10 years of industry/business experience, including at least 4-6 years in the pharmaceutical industry.
- Experience in areas such as manufacturing, active pharmaceutical ingredient, drug product development, CMC regulatory, analytical development, etc.
- A working knowledge of drug development
- Experience in developing a health authority dossier is preffered
Over de werkgever
Pharmaceutical company specialised in the development of vaccins.
Wat wij bieden
- Secondment via CheckMark Labrecruitment for 1 year with a possible extension of 6 months
- Parttime position for 20 hours/week (flexibility to 16 hours/week)
Uren per week:
Neem voor meer informatie contact op met Jurjen Wilschut: 0182 590 212