This organization is focused on Gene Therapy to treat immunological diseases. Gene Therapy uses genes to treat diseases by deleting, adding or altering DNA, this way it targets the root cause of the problem instead of just treating the symptoms. This firm uses viruses and vectors to get into the cell to deliver the new copy of the gene into a cell.
As a CMC Leader you will responsible for defining the strategy and timelines for all CMC development activities of the gene therapy program.
- - Developing strategy and timeliness for all CMC development activities
- - Guiding and coordinating all in house and external CMC development activities
- - Providing scientific expertise and leadership to the CMC team(s)
- - Taking active part in preparation of briefing documents and responses to regulatory quarries
- - Taking active part in teleconferences and face -to- face meeting with regulatory authorities as needed
- - Establishing a CMC development record tracking system
- - Interacting with research groups to provide insight and optimize transition of research programs to development activities
- - Establishing good communication and collaborative relationship with cross-functional colleagues
- - Aiding technology transfer for both process and analytics
- - Developing junior team members by providing technical guidance and support
- - Holds a PhD (Bio-sciences e.g. biotechnology, virology, biochemistry, molecular biology) with at least 10 years of relevant experience. Alternatively, in certain circumstances, holds MSc with 15+ years of relevant work experience
- - Possesses extensive experience (+7 years) in development of ATMPs
- - Understands regulatory framework regarding ATMPs (EP, USP, ICH, EMA/FDA guidelines)
- - Proven track record of involvement in successful IMPD/IND filings
- - Possesses experience in process or analytical development of ATMPs
- - Experienced in multiple areas from the following: insect cells/BEVS bioprocessing, rAAV, gene therapy is an advantage
For more information please contact Carla Garcia at email@example.com or +31 (0) 20 658 98 01.