Process Development Project Leader

Qualifications:
MSc/Ph.D. (preferable) in Biotechnology Engineering/Biology.
Hands-on experience in growth and characterization of mesenchymal stem cells.
Hand on experience in molecular biology and tissue engineering.
Industrial experience in manufacturing process development and scale-up.
Experience with bioreactor process.
Hands-on skills in immune-based assays (immunofluorescence, flow cytometry, ELISA, etc.) .
Experience with biological delivery systems (liposomes, exosomes, etc.) - a plus.
Excellent oral presentation and writing skills in English.
Responsibilities:
Development of mesenchymal stem cells expansion methods in a bioreactor.
Development of master and working cell banks.
Development and qualification of batch release and in process control assays (in house/outsourced).
Development of a scaled-up industrial manufacturing process.
Writing SOPs, reports, analytical methods, and related CMC sections in regulatory submissions.