What will your job be
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
What are we looking for
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
What do we offer
- 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)
Where will you work
Pharmaceutical company specialised in the development of vaccins.