CMC Project Leader - Eurocine Vaccines AB - Avslutad

You will be part of the Eurocine Vaccines R&D team being responsible of all CMC aspects in company R&D projects contributing to develop the company technical platform as well as the vaccine project. You will have responsibility to drive and manage the supply of Drug Substance under an existing supply agreement as well as the manufacturing processes and quality control of Drug Products employing contract research (CRO) and contract manufacturing organizations (CMO). You will also have responsibility to manage contact with pharmaceutical agencies within his or her field. 

Key responsibility areas

  • As member of the R&D team support and influence the vaccine project concerning all CMC matters and aspects
  • Contribute with expert CMC knowledge in projects and other company activities including advising on technical as well as strategic steps needed to be taken
  • Responsibility to drive and manage formulation and manufacturing processes using CRO’s and CMO’s
  • Responsibility to drive and manage quality control aspects using CRO’s and CMO’s
  • Take responsibility for communication with CRO’s and CMO’s making sure that the CRO or CMO delivers what is agreed upon concerning Drug Product and needed documentation
  • Responsibility for the generation and review of necessary CMC documentation
  • Managing contacts with pharmaceutical agencies both in Sweden and internationally
  • Responsibility for CMC documentation for Clinical Trial Applications including preparation of IMPD documentation

Your profile

  • MSc in Pharmacy or a PhD or other qualified university degree in any other relevant area
  • Broad and qualified experience of drug development of biologics or small molecule pharmaceuticals with focus on CMC
  • Experience of work in core-teams or project teams representing CMC
  • Experience in preparation of regulatory CMC documentation for Clinical Trial Application (CTA)
  • Experience of up-scaling process development of Drug Product to commercial scale
  • Knowledge in QA and GMP requirements is an advantage
  • Knowledge in physical chemistry is an advantage
  • Experience of work with intellectual property matters is an advantage

More information and application

Eurocine Vaccines is cooperating with the recruitment agency Aktivia Science Work in this recruitment. If you have any questions please call Knut Natt och Dag at +46 722 16 68 00. Send us your application at knut.nattochdag@aktivia.se as soon as possible due to our ongoing effort with this recruitment. Please include “CMC Project Leader” in the subject field.

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