PDC*line Pharma is recruiting a QC and Process Development Manager

 

The candidate will have as primary mission:

  • Establish and manage the QC activities of PDC*line Pharma
  • Participate with the cell therapy unit of EFS French Blood Bank in Saint-Ismier (France) in the development of the production process
  • Carry out the proof of concept of the ready for use formulation of and demonstrate the bio comparability of the drug product with the existing product
  • Manage the validation of analytical methods
  • Manage external contractors for quality control
  • Assist in the preparation of the compliance of operations GMP QC

 

Required Skills / Experience:

  • Minimum of 5 years in the pharmaceutical or biotechnology companies experience in an equivalent position
  • Knowledge of methods QC (PCR, FACS …)
  • Experience in cell culture and in the development of manufacturing method
  • Experience in the pharmaceutical regulatory environment EMA
  • Experience in team management and project management
  • Fluency in English, both written and oral. Fluency in other languages ​​would be an advantage

 

Contract:

  • Remuneration to be discussed in relation to experience
  • Job mainly based in Liège (Belgium)

 

Application

Send your motivation letter and cv to contact[at]pdc-line-pharma.com

PDC*line Pharma receives Advanced-Therapy Medicinal Product (ATMP) classification from the European Medicines Agency (EMA) for its new class of therapeutic cancer vaccines (PDC*vac)

June 15th 2015 – The Philadelphia 2015 BIO International Convention (US) and Grenoble (France) – PDC*line Pharma, a clinical-stage biotech company, announces that PDC*vac, its new class of therapeutic cancer vaccines based on a line of Plasmacytoid Dendritic Cells (PDC*line), was granted Advanced-Therapy Medicinal Product (ATMP) classification by the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA), in consultation with the European Commission. The EMA / CAT considers that PDC*vac fulfills the definition of an Advanced-Therapy Medicinal Product (ATMP), within the Somatic-Cell Therapy Medicinal Product category.

Laurent LEVY, co-founder & CEO of PDC*line Pharma, commented: “The granting of ATMP classification for PDC*vac is a key milestone in the development of our new class of therapeutic cancer vaccines. This classification enables us to receive centralized scientific advice and guidance from the EMA / CAT and to file for the Marketing Authorization at the European level. In addition, PDC*line Pharma is now eligible to benefit from incentives for Small and Medium size Enterprises (SME) developing an ATMP.”

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