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
- Remuneration to be discussed in relation to experience
- Job mainly based in Liège (Belgium)
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.”
PDC*line Pharma received €500 k in grants and won 3 awards in 2014: the Worldwide Innovation Challenge 2030, the i-Lab French competition, and the French plan “medical biotechs”.
PDC*line Pharma was selected for the Medical Biotechnology industrial plan.
A reception has taken place at the Elysee Palace for the 110 award recipients of the Worldwide Innovation Challenge 2030.
PDC*line pharma has been declared as a national winner of the 2014 edition of the French competition for creation of innovative companies, in the “creation – development” category.
PDC*line Pharma has been selected to present at Biovision Investor Conference on June 5, 2014.
Grenoble CHU and EFS started the clinical trial GeniusVac-Mel4