CEO
Bioactive pharma
Total des années d'expérience :36 years, 5 Mois
My private company
has the following products
B.C.A.A. LEBAN 50g SACHET is the generic form of Aminoleban "Liver cirrhosis",
Hand to hand 50g SACHET is the generic form of Impact "Immuno-nutrition for Surgical and Trauma Patients",
Mushotag CAPSULE is the generic form of ReishiMax GLp for Optimal Immune System Support
Opacide is the generic form of CIDEX OPA (for endoscope disinfection),
Currently, 5 lyophilized vial products (under registration)
Follow up all Genzyme’s activities within MENA countries especially GCC
Monitoring and setting appropriate Genzyme's timelines for licensing, marketing and legal compliance of pharmaceutical and medical products, in order to control the safety and efficacy of products.
Coordinate the manufacturing site's auditing and all ME governmental issues.
Follow up the regional clinical studies and Pharmacovigilance activities
Start up JULPHAR’s Biotechnology project, and supervising the technology transfer of EPO raw material manufacturing and fill/finish phase
My main achievements were:
Scale up the manufacturing phase of EPO and fine tuning technical variation
Registered the EPO file in 34 different countries
Technical advisor for FDA audit (2005) and EU audit (2006)
Coordinating and preparing the registration files for biosimilars to (Epgogen, Avonex, Humulin, Filgrastim and Intron A).
Organizing, train and running a diverse microbiology laboratory all microbiological activities and environmental control
Update the quality system (passed EMEA and FDA audits)
Water microbiological monitoring
Sterile area validation
Supervise all microbiological activities and environmental control
Sterile area validation
Supervise all microbiological activities and environmental control
Aseptic area validation
Perform all microbiological activities and environmental control
Excellent Physiological and Biological Studies on the Resistance Ph. D concerned with bacterial resistance due to σs regulator genes that control multi-resistance
TOEFL score : 661 points. ELTS (British council) : Grade A (Scientific) Three courses of German language
“Fate of Medically Important Bacteria In Some Pharmaceutical & Cosmetic Formulations”
microbiology / chemistery