Project Director CMC - Stockholm - Avslutad
The client company is an innovative pharmaceutical company developing drugs to meet disease treatment needs in large widespread diseases. The company is on the Stockholm Excange.
Key Responsibilities:
- Responsible to independently manage CMC-projects concerning company development projects
- Responsible for creation of documents that enables manufacturing companies and CRO''''''''s to deliver properly
- Work with quality issues in close collaboration with the QA function
- Be on of the company contact person working with out-licensing of development projects
- Monitoring the market to identify suitable partners for chemistry, pharmacy, up-scaling of compounds and manufacturing
- Making sure that chemistry, up-scaling and manufacturing is hold together as well as pharmacy and manufacturing of clinical trials material
- Perform audits at contract companies working with chemistry, pharmacy, up-scaling and manufacturing
Education and experience:
- Academic education within Process Chemistry or Chemistry. Education in matters concerning up-scaling is an advantage
- Qualified experience from independent work with CMC matters
- Good knowledge about the regulatory affairs role in preclinical development and CMC work
- Experience of work with up-scaling of compounds are an advantage
- It''''''''s of importance with knowledge within Process R&D but it''''''''s also important to have broad experience in pharmacy
For more information about the position call:
Knut Natt och Dag. Phone: +46 722 166 800. Email: knut.nattochdag@sciencework.nu or Rolf Mayer. Phone: +46 708 87 60 05. Email: rolf.mayer@sciencework.nu