Hamdy Kandil, CEO

Hamdy Kandil

CEO

Bioactive pharma

Location
Egypt
Education
Doctorate, Microbiology
Experience
36 years, 4 Months

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Work Experience

Total years of experience :36 years, 4 Months

CEO at Bioactive pharma
  • Egypt - Cairo
  • My current job since January 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 at Genzyme Europe PV
  • Netherlands
  • April 2007 to January 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 at JULPHAR Gulf Pharmaceutical
  • United Arab Emirates - Ras Al Khaimah
  • January 2001 to April 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 at JULPHAR Gulf Pharmaceutical
  • United Arab Emirates - Ras Al Khaimah
  • September 1998 to January 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 at SEDICO Pharmaceutical
  • Egypt
  • February 1995 to September 1998

Supervise all microbiological activities and environmental control
Sterile area validation

head of microbiology laboratory at UTAC Cosmetics
  • Egypt - Cairo
  • May 1989 to February 1995

Supervise all microbiological activities and environmental control
Aseptic area validation

Microbiologist at | EIPICO Pharmaceutical Company
  • Egypt - Cairo
  • January 1988 to April 1989

Perform all microbiological activities and environmental control

Education

Doctorate, Microbiology
  • at Zigzag University
  • January 1999

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

Doctorate, Microbiology
  • at Cairo university
  • January 1998

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

Master's degree, Microbiology
  • at El mansoura University, EgyptCairo University
  • January 1994

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

Bachelor's degree, Microbiology
  • at Ain Shams UniversityCairo UniversityAmerican University of Cairo
  • June 1986

microbiology / chemistery

Specialties & Skills

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

Languages

English
Expert
Arabic
Native Speaker

Memberships

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

Training and Certifications

Current Good Manufacture Practices (Training)
Training Institute:
Beirzdorf
Date Attended:
March 1992
Biotechnology transfer (Training)
Training Institute:
International Center for Genetic Engineering and Biotechnology
Date Attended:
November 2007
Validation of microbiological methods (Training)
Training Institute:
Lancôme cosmetic factories
Date Attended:
February 1992

Hobbies

  • chess
  • Reading
  • Football