CMC Project Leader - Medivir - Avslutad

You will be representing CMC as core team member in project core teams in preclinical and development projects. You will advise on needed substance characterization and on synthesis documentation for Candidate Drug nomination. You will also manage development of manufacturing processes for Drug Substance and Drug Product employing contract research organizations (CRO) as well as contract manufacturing organizations (CMO). Your responsibility will also be to manage manufacturing of drug substances for preclinical studies and Investigational Medicinal Products (IMP) for clinical studies at CMOs. In addition to this, you will oversee distribution of IMP to clinical sites, performed by specialized distribution companies. Work with summarization of documentation for Clinical Trial Applications (CTA) including preparation of IMPD documentation will also be within your responsibility.

What you need to bring?

  • A university degree in chemistry, pharmaceutical science or technology (chemistry)
  • Experience of work with evaluation and choice of CMOs to be used in CMC development
  • Knowledge in QA and GMP requirements in different stages of development including phase III projects
  • Experience of work in development projects
  • Experience in preparation of regulatory CMC documentation for Clinical Trial Applications from phase I to phase III
  • Experience from work with managing CMOs for distribution of clinical supply in phase I to phase III studies
  • Experience of chemical process development and/or pharmaceutical development

You also need to have good knowledge and ability in English and Swedish both in speech and in writing

More information and application

Please call Knut Natt och Dag on +46 722 16 68 00 if you want to have more information or want to discuss this recruitment project. Send your application containg of a personal letter and your CV to knut.nattochdag@aktivia.se. Write "CMC Project Leader Small Molecules" in the subject field. We are working continuously with this recruitment project and would like to have your application as soon as possible.

Aktivia Science Work AB is a recruitment agency within Life Sciences. We are members in SwedenBIO and Medicon Valley Alliance. You can read more about us at our website - www.aktivia.se.

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