Technology Transfer Manager | 15+yrs in the Pharma Industry | B.Sc. Pharmacy | M.Sc. Quality Management | CQM/OE | PMP | MBA Candidate

1. 1 Curriculum vitae
Industry-based pharmacist
Personal Information:
Education and Certificates:
Faculty Of Pharmacy-Cairo University
Degree :B.Sc. in Pharmaceutical Science May 2004
Appraisal Good "70%, Last Year "Very Good
American Society for Quality
Certified Manager of Quality Organizational Excellence 2011
Arab Academy For Science and Technology and Maritime Transport
Degree: Master in quality management June 2014
Master Thesis: Lean Quality /Production Management
Project Management Institute
Certified Project Management Professional (PMP) Dec 2020
Skills:
Computer skills
Operating System WIN 9x, 2000, NT, XP, Windows 7,8 and 10 and Linux
Microsoft Office 365, Share point, Power PI, MS Forms, MS Teams, MS Project, and MS Planner.
Statically Programs Minitab 18, SPSS Statistics and JMP 15
Languages
Arabic Mother Tongue.
English Very Good.
Commitment to Quality:
Able to implement all cGMP, GLP Rules.
Knowledge of FDA and ICH guidance.
Familiar with HACCP rules and ISO 9001-2015.
Basic Six Sigma awareness.
Work skills
15 years in Quality Assurance, Quality Control, and manufacturing environment within pharmaceutical industry.
Ability to work with sophisticated technology and interest in continued learning.
Analytical/critical thinking and problem-solving skills.
Strategic oriented project management knowledge and skills
Leading teams from wide various multinational backgrounds.
Training and Certificates:
 Kahera for Pharmaceutical and Chemical Industry internship for 4 years (2000-2004)
 Evaluating Analytical Data, Calibrations, Standardizations, and Blank Correction. Alkan and Lilly Egypt
 Fermentation Special aspects HIRUDIN-INTERFERON MIINAPHARM Biogenetics - RHEIN
 Principles of filtration, sterilizing filter qualification, main Biopharma applications, products and materials
 Quality by design robust HPLC Methods Dry Lab® Molnár-Institut für Angewandte Chromatographie.
 Internal Auditing of Quality Management Systems ISO IEC 9001: 2000
 Competence of Testing and Calibration Labs. Sys. ISO/IEC 17025:2005
 TOT “Trains of Trainers “And TTT "Training the Trainers"
 Implementation of LIMS on (Row Material-Finished Product-Environmental Monitoring-Stability-QMS). Novatek
 LC-MS Waters Customer Training Course.
 Evaluation and Trending of process Data for continued process verification and annual product quality review ECA
 Technology transfer and Full Analysis of Lipitor and Amlor Pfizer.
 Project Management Certification Training Program (PMP). Mediterranean Management Center Cyprus.
Birth Date Jan 10, 1983
Gender Male
Marital Status Married
Nationality Egyptian
Resident of Cyprus – Limassol_ Kato Polimedia
Military Service Finished in Matroh Military Hospital.
Contact Information »
: 36 Ilia Iliadi, Limassol, 4154, Cyprus
: +35795795747
: muhamadgamaleldean@gmail.com
: www.linkedin.com/muhamad-abdalkader

2. 2 Curriculum vitae
Academic Courses:
• Advanced Total Quality Management.
• Management of Human Resources.
• Advanced Statistical Quality Control.
• Advanced Quality Assurance.
• Macroeconomics & Microeconomics.
• Knowledge Management.
• Contemporary Strategic Management.
• Financial Management for Contemporary Organizations.
• Projects Management
• Business Process Reengineering.
• Contemporary Management.
• Competing in Global Environment.
• Statistics for Management Decision.
• Management Information Systems.
• Customer behavior.
• Group Dynamics.
• Research Methodology.
• Advanced Topics of T.Q.M.
Job Experience:
Medochemie Ltd (Cyprus): February 2018-Until Now
Technology Transfer Manager-Coordinator (November 2019- Now)
Description :
1. Collaborating with Quality, Engineering, and Manufacturing to ensure
robust process/methods transfer.
2. Provide technical leadership for the tech transfer of products and processes to ensure a smooth transition.
3. Directs and supports activities related to the successful manufacture of a new product or existing product stability
and validation batches through coordination and communication of the involved departments.
4. Plans work schedules and personnel to accomplish the required duties on time according to approved schedules.
5. Develops and recommends the product validation matrix.
6. Cooperate with the Regulatory department to assure the provision of needed documentation for registration.
7. Monitor risk involved in manufacturing a product and develop/review the validation protocol.
8. Identifies and implements process improvements designed to improve efficiency and enhance product quality.
Analytical Technology Transfer Manager (January 2018- November 2019)
Description :
1. Supervise, organize, and execute analytical method transfer within internal or external Sites.
2. Participate in transfer meetings to ensure that milestones are met and take part in decision-making.
3. Evaluate offers and prepare Costing proposals for Contract Manufacturers.
4. Compile data/history from R&D, QC Routine work, Stability, and Validation.
5. Perform Risk Assessment; evaluate internal gaps and helping to avoid any deviations during transfer.
6. Assure compliance with procedures and regulations by requesting and monitoring corrective actions as necessary.
7. Proposal of Analytical Method modifications and interact with all laboratories to support investigation or
troubleshooting activities as needed, by suggesting and recommending alternative methods and procedures.
8. Define training requirements, organize training, and assure that personnel received the training whenever new
methods/procedures are introduced and Provide troubleshooting support.
9. Set acceptance criteria, Prepare Inter Lab Protocols for Analytical methods, and Comparative Dissolution.
10. Prepare transfer package (Materials Checklists, Example chromatograms, Trends QC/stability data,
Spreadsheets/calculations, Working Standards, Related Substances, Samples, Reagents and Columns)
11. Perform and approve the transfer and evaluate site results and transfer the final report.
Phytosciences Consultants (USA / Remote / Part-time) December 2014- February 2018
Compliance Officer and Formulation Scientist
Description :
1. Design formulation and process optimization.
2. Develop and execute a development plan policies, SOPs, guidance,
etc. based on prioritized needs.
3. Develop and execute a plan for ensuring compliance with federal and state requirements.
4. Assist with training efforts.
Qualifications:
1. Ability to communicate and work with many disciplines, such as management, scientists, physicians, information
systems specialist, state, federal, and international agency officials, and others.
Sigma Pharmaceuticals Industries (Egypt): August 2008- July 2017
Solid Dosage forms Formulation Unit Head:(May 2013- July 2017)
Description :
1. Design, execute, and interpret the formulation and process
development of various oral pharmaceutical dosage forms.
2. Manufacture clinical supplies to support preclinical and clinical studies of elected pharmaceutical formulations.
3. Prepare necessary documentation for preclinical in vivo and/or in vivo/in vitro screening.
Analytical Methodology and Stability Unit Head:(August 2008- May 2013)
Description :
Job Title: Project Manager
Industry: Pharmaceuticals
Function: Operations
Job Title: Scientist
Industry: Distance Consultancy
Function: R&D.
Job Title: Unit Head
Industry: Pharmaceuticals
Function: R&D.

3. 3 Curriculum vitae
1. Develop a method to test new chemical entities and impurities/degradants in the finished products.
2. Develop validate and troubleshot stability-indicating testing methods for new chemical entities.
3. Coordinate with Quality Control and production departments to transfer the method to QC Labs.
4. Prepare Stability Protocol and Testing Summary of active pharmaceutical ingredients and drug products.
Qualifications:
1. Expertise working with laboratory instrumentation including HPLC, GC, LC/MS/MS, Dissolution, UV-Vis, etc.
2. Good knowledge in Preparation of stability schedule /Preparation of stability protocols/Photo Stability
studies/Preparation & review of Analytical Worksheets/Periodic calibration of the instruments.
RHEIN-MIINAPHARM Biogenetics (Egypt): September 2007 -August 2008
Fermentation and Purification Area Specialist:
Description :
1. Assuring that the manufacturing equipment and processes are
meeting safety, quality standards, and continual improvements.
2. Works with other departments, and provides support for
fermentation, recovery, and purification processes.
3. Troubleshoots and resolves highly complex equipment problems and takes corrective action.
4. Writes operating procedures to incorporate new or changing equipment, products, and processes.
5. Works with scientists to report the results of experiments and analyzes data to assist in technology transfer.
6. Completes all required documentation for proper traceability purposes.
7. Maintains accurate production records to comply with regulatory requirements.
Qualifications:
1. Experience with equipment such as stainless steel tanks, bioreactors, centrifuges, filtration systems,
chromatography systems, control systems (DCS, PLC, SCADA, etc.), and CIP/SIP systems.
2. Experience with microbial fermentation, protein refolding, and protein purification.
Lacto Misr For Baby Milk September 2006 –September 2007
Quality control Analyst.
1. Chemical Analysis of raw materials and finished products.
2. Performing method validation for new analytical methods.
3. Water-Full Analysis for the RO station.
Kahera Company for Pharmaceutical and Chemical April 2006 -September 2006
Job Title: Specialist, Manufacturing
Industry: Biopharmaceuticals
Function: Operations/Manufacturing
Area: Class A ,B ,C
Job Title: Junior Analyst,
Industry: pharmaceuticals
Function: Quality Control.
Quality Assurance in-process Control Officer at all dosage forms Facilities.
1. Conducting quality audits as required to ensure compliance with
GMP, Quality standards, and sterility regulations throughout the
field.
2. Carrying out material sampling as needed to conduct QA audits.
3. Performing pre and post-production quality checks.
4. Ensuring compliance of plant conditions with set guidelines.
5. Checking machine conformity to standards as well as ensuring periodic maintenance implementation.
Work and academic Achievements:
2021 MBA student at the European University of Cyprus-Business school.
2020 Certified Project management professional (PMP).
2019 Obtain Credit ours needed for PMI Certification Exam
2018 Leading transfer of 30 products to Medochemie Far East from Medochemie Cyprus, Janson, and Pfizer
2016 Managing teams of Solid Dosage form formulation and technology transfer to more than 200 products.
2015
Trainer for technical knowledge related to GLP, cGMP, and Pharmaceutical Impurities.
Joined consultancy team that involves global collaboration from the USA, India, and Canada.
2013 The first project completed by the team was in applying lean Six sigma quality control laboratories.
2011 Certified Manager of Quality Organizational Excellence from the American Society of Quality.
2010 1 year of academic study to pass the ASQ exam to be certified manager of quality
2009-2012 Leading analytical methods validation team to finish more than 150 analytical test methods.
2008 Developing a macro-enhanced application to monitor multiple parameters in the fermentation process and
study the impact of deviation on the purity of the final product using Quality by design principles.
2007 Assistant in a one-year project between Lactomasr (Egypt) and BRAN+LUEBBE (Germany) to employ
near-infrared spectroscopy NIR in routine analysis of proteins, Fats, and Fatty acids.
2006 joined a cross-functional team in Kahira Pharmaceuticals to establish cleaning validation protocols in
compliance with the Egyptian Ministry of Health and WHO requirements.
Issued on 03/01/2021
Job Title: Junior Analyst,
Industry: pharmaceuticals
Function: Quality Control.