حمدي قنديل, CEO

حمدي قنديل

CEO

Bioactive pharma

البلد
مصر
التعليم
دكتوراة, Microbiology
الخبرات
36 years, 5 أشهر

مشاركة سيرتي الذاتية

حظر المستخدم


الخبرة العملية

مجموع سنوات الخبرة :36 years, 5 أشهر

CEO في Bioactive pharma
  • مصر - القاهرة
  • أشغل هذه الوظيفة منذ يناير 2013

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)

Middle East Regulatory Affairs Manager في Genzyme Europe PV
  • هولندا
  • أبريل 2007 إلى يناير 2013

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

Biotechnology Plant Manager في JULPHAR Gulf Pharmaceutical
  • الإمارات العربية المتحدة - رأس الخيمة
  • يناير 2001 إلى أبريل 2007

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).

head of microbiology laboratory في JULPHAR Gulf Pharmaceutical
  • الإمارات العربية المتحدة - رأس الخيمة
  • سبتمبر 1998 إلى يناير 2001

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

head of microbiology laboratory في SEDICO Pharmaceutical
  • مصر
  • فبراير 1995 إلى سبتمبر 1998

Supervise all microbiological activities and environmental control
Sterile area validation

head of microbiology laboratory في UTAC Cosmetics
  • مصر - القاهرة
  • مايو 1989 إلى فبراير 1995

Supervise all microbiological activities and environmental control
Aseptic area validation

Microbiologist في | EIPICO Pharmaceutical Company
  • مصر - القاهرة
  • يناير 1988 إلى أبريل 1989

Perform all microbiological activities and environmental control

الخلفية التعليمية

دكتوراة, Microbiology
  • في Zigzag University
  • يناير 1999

Excellent Physiological and Biological Studies on the Resistance Ph. D concerned with bacterial resistance due to σs regulator genes that control multi-resistance

دكتوراة, Microbiology
  • في Cairo university
  • يناير 1998

TOEFL score : 661 points. ELTS (British council) : Grade A (Scientific) Three courses of German language

ماجستير, Microbiology
  • في El mansoura University, EgyptCairo University
  • يناير 1994

“Fate of Medically Important Bacteria In Some Pharmaceutical & Cosmetic Formulations”

بكالوريوس, Microbiology
  • في Ain Shams UniversityCairo UniversityAmerican University of Cairo
  • يونيو 1986

microbiology / chemistery

Specialties & Skills

Quality
Regulatory Affairs
Pharmaceuticals
Microbiology
Biotechnology
AUDITING
BUSINESS PLANS
MICROSOFT MAIL
ORGANIZATIONAL SKILLS
QUALITY
SUPERVISORY SKILLS
VALIDATION

اللغات

الانجليزية
متمرّس
العربية
اللغة الأم

العضويات

Parenteral Drug Association
  • ME
  • January 2012
Pharmacovigilance Association
  • ME
  • January 2013

التدريب و الشهادات

Current Good Manufacture Practices (تدريب)
معهد التدريب:
Beirzdorf
تاريخ الدورة:
March 1992
Biotechnology transfer (تدريب)
معهد التدريب:
International Center for Genetic Engineering and Biotechnology
تاريخ الدورة:
November 2007
Validation of microbiological methods (تدريب)
معهد التدريب:
Lancôme cosmetic factories
تاريخ الدورة:
February 1992

الهوايات

  • chess
  • Reading
  • Football