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Bassem Adel Fayed
Research And Development Manager
Riyadh,Malaz
Summary
I am multifunctional professional with more than 15 years of experience in the pharmaceutical field. Worked and championed the development and transfer of complex and challenging products in the MENA region. Developed a strong background on product registration in different countries. Self-motivated with an international GMP certificate and six sigma black belt. Well-developed skills in both Quality Assurance and Quality Control systems working with regulatory agencies such as GCC, and EDA. Inherent ability to interpret and explain analytical technical documents, compendia requirements, and regulatory body documents. I am keen on an opportunity to develop expertise in the fields related to my experience and studies. It is thus my desire to utilize my scientific, pharmaceutical, communication and computer skills as an active R&D Manager. I also have a transferable IQAMA in Saudi Arabia in addition to the Saudi professional certification of pharmacy, which needs renewal.
Overview
22
22
years of professional experience
17
17
years of post-secondary education
3
3
Certificates
Work History
Research and Development Manager
Jazeera Pharmaceutical Industries, HIKMA
Riyadh, Malaz
04.2019 - Current
- · Perform technology transfer of new products to our facility for different dosage forms as solids, liquids and semisolids.
- · Develop new products from scratch for different dosage forms as solids, liquids and semisolids, according to quality by design and latest guidelines.
- · Improve/ optimize current products regarding process, stability and other features.
- · Register new products according to latest authorities’ guidelines (GCC).
- · Troubleshooting challenges during different manufacturing procedures of current products for different pharmaceutical dosage forms.
- · Handle deficiency letters, if any, during registration process, and response on time.
- · Review and approve DMF, CEP documents of suppliers of APIs.
- · Review and approve CTD of finished product for registration purposes.
- · Review and approve analytical method validation required for every product.
- · Follow GMP guidelines for producing, analyzing submission batches for registration purposes.
- · Review and approve CoAs of APIs, excipient, finished products, and stability results of submission batches for registration purposes.
- · Prepare budget, plan for new products. Leveraged data and insights to inform conclusions and support decision-making. Partner with sales, strategy, and business development to identify new product opportunities, manage project portfolio and work assignments. Coordinate with purchasing department to identify new materials and technology.
- · Review staff competencies to build employee skill sets based upon future technical requirements. Mentor local personnel on best practices and protocols to maximize productivity. Support collaborative projects and work closely with technical partners to deliver against portfolio road maps.
- · Use multiple sources of information and broader stakeholder views to develop solutions and recommendations. Liaise with key stakeholders to understand business requirements and expectations and develop strategic direction to R&D performance materials.
- · Create process recipes and conducted statistical analysis to define specifications and determine equipment capabilities. Work with global cross-functional teams to gain alignment and move initiatives from product ideas to commercialization. Achieve profitability goals by developing and implementing commercial activities.
- Develop creative presentations, trend reports, kitted assets, and product data sheets. Align activities with corporate objectives by coordinating marketing, sales and IT processes.
R&D Manager
Future for pharmaceutical industries
Cairo, EGYPT, Badr
09.2015 - 01.2019
- · Identify and determine R&D workload. Categorize R&D workloads. Convert R&D workload to monthly, quarterly and annually objectives that match company general objectives. Put action plan to achieve R&D objectives with defined time frame. Allocate R&D workload to the department available manpower and equipment to achieve its work plan.
- · Report and follow up all department achievements on daily basis and to plant manager, monthly and quarterly basis.
- · Communicate with other departments in a professional and effective way to achieve goals.
- . Assess and evaluate performance of all subordinates on quarterly basis.
Quality Control and R&D Manager
EGYPHAR
Cairo, EGYPT, Obour
04.2014 - 08.2015
- · Planning for QC activities.
- · Reviewing and issuing all QC related SOPs.
- · Water station.
- · Update of QC along with new products and customer requirements.
- · Reviewing process and cleaning validation.
- · Reviewing stability files for submission to MOH. Reviewing the files of new products to be issued and produced.
- · Implementation of GMP.
- · CoAs release.
- · Developing and evaluating formulation of new products.
- · Preparing files for registration (Local and Export) as needed.
- Launching new products.
Quality Operations Manager
Atos Pharma (SEKEM)
Cairo, Belbeis
02.2013 - 04.2014
- Resolved problems, improved operations and provided exceptional service.
- Created plans and communicated deadlines to ensure projects were completed on time.
- Led projects and analyzed data to identify opportunities for improvement.
- Served customers and followed outlined steps of service.
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
- Developed team communications and information for meetings.
- Used coordination and planning skills to achieve results according to schedule.
QC Manager
Atos Pharma (SEKEM)
Cairo, Belbeis
11.2011 - 02.2013
- Developed and analyzed quality control processes and deliverables to determine present standards and establish recommended action plans.
- Kept equipment operating and in good condition by performing quality checks and calling in for repairs when needed.
- Updated quality control standards, methods and procedures to meet compliance requirements.
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
- Evaluated GMP and ISO 17025 systems for overall functionality, identified opportunities for improvement and implemented changes to facilitate better outcomes.
- Documented inspection results by completing logs.
- Rejected defective products and approved correct products.
QC and R&D Manager
Biopharm
Cairo, Giza
01.2011 - 10.2011
- Used Microsoft Word and other software tools to create documents and other communications.
- Maintained energy and enthusiasm in fast-paced environment.
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
- Prepared a variety of different written communications, reports and documents to ensure smooth operations.
- Resolved conflicts and negotiated mutually beneficial agreements between parties.
- Improved operations through consistent hard work and dedication.
- Offered friendly and efficient service to customers, handled challenging situations with ease.
- Carried out day-day-day duties accurately and efficiently.
QC Manager
RIVA Pharma
Cairo, Cairo
09.2009 - 08.2010
- Kept equipment operating and in good condition by performing quality checks and calling in for repairs when needed.
- Developed and analyzed quality control processes and deliverables to determine present standards and establish recommended action plans.
- Updated quality control standards, methods and procedures to meet compliance requirements.
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
- Documented inspection results by completing logs.
Supervisor of Chemistry Lab
RIVA Pharma
Cairo, Cairo
05.2007 - 11.2008
- Offered friendly and efficient service to customers, handled challenging situations with ease.
- Used Microsoft Word and other software tools to create documents and other communications.
- Maintained energy and enthusiasm in fast-paced environment.
- Resolved problems, improved operations and provided exceptional service.
- Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.
- Worked flexible hours; night, weekend, and holiday shifts.
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
- Delivered products to customer locations within specific timeframes.
- Prepared a variety of different written communications, reports and documents to ensure smooth operations.
Chemical Analyst
National organisation of drug control and research (NODCAR)
Cairo, Giza
11.1999 - 06.2008
- Operated laboratory equipment and prepared compounds and solutions to conduct tests.
- Performed chemical tests to assist scientists in making qualitative and quantitative analyses of solid, liquid and gaseous materials.
- Calibrated and maintained laboratory spectrometers and chromatographs.
- Created spreadsheets and other forms of documentation to accurately record and calculate analytical results.
- Applied chemistry knowledge and expertise to enhance analytical applications.
- Efficiently organized and maintained equipment to keep laboratory productive and safe.
- Composed technical reports and charts to document experimental test results.
- Collaborated with supervision, engineering and other personnel on quality and performance improvements.
Education
MBA - Business Administration And Management
The Arab Academy For Science, Technology & Maritim
Alexandria 11.2021 - Current
Ph.D. - Pharmaceutics
Cairo University, College of Pharmacy
Cairo 01.2011 - 04.2017
Master of Science - Pharmaceutics
Cairo University, College of Pharmacy
Cairo 01.2002 - 04.2008
Bachelor of Science - Pharmacy
Cairo University, College of Pharmacy
Cairo 09.1994 - 07.1999
Skills
Leadership and managerial skills
undefinedAccomplishments
· Successfully registered about 18 drug product with different strengths in 2021.
· Successfully submission of 15 drug product with different strengths to SFDA in 2021.
· Manufacturing of about 5 new drug products in 2021.
· Resolved 3 product issues regarding stability and productivity in 2021.
· Achieved less SFDA DLs for API DMF by introducing software for impurities and genotoxicity.
· Development of more than 10 new products and its scale up in future company along one year.
· Participation in successful passing of many multinational GMP audits in future company (Abbot, SANDOZ)
· Participation of successful passing of foreign authorities GMP audits in future company (SUDAN, YEMAN)
· Successful improvement of many current product processing instructions and formula in future company to meet customer satisfaction.
· Successful registration of future company products in many countries (Sudan, Yemen)
· Successful registration of EGYPHAR products in many African countries (Tanzania, Uganda and others)
· Successful passing ISO 17025 for laboratories for the re-accreditation of Atos Pharma lab at Jan 2014.
· Egyptian MOH approval for Atos Pharma factory opening in Feb 2012.
Certification
GMP (ASQ)
Interests
Athletics
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins
Timeline
MBA - Business Administration And Management
The Arab Academy For Science, Technology & Maritim
11.2021 - Current
Research and Development Manager
Jazeera Pharmaceutical Industries, HIKMA
04.2019 - Current
CMQ (ASI)
12-2015
R&D Manager
Future for pharmaceutical industries
09.2015 - 01.2019
Quality Control and R&D Manager
EGYPHAR
04.2014 - 08.2015
Quality Operations Manager
Atos Pharma (SEKEM)
02.2013 - 04.2014
GMP (ASQ)
12-2011
QC Manager
Atos Pharma (SEKEM)
11.2011 - 02.2013
QC and R&D Manager
Biopharm
01.2011 - 10.2011
Ph.D. - Pharmaceutics
Cairo University, College of Pharmacy
01.2011 - 04.2017
Six Sigma Black Belt (ASQ)
10-2010
QC Manager
RIVA Pharma
09.2009 - 08.2010
Supervisor of Chemistry Lab
RIVA Pharma
05.2007 - 11.2008
Master of Science - Pharmaceutics
Cairo University, College of Pharmacy
01.2002 - 04.2008
Chemical Analyst
National organisation of drug control and research (NODCAR)
11.1999 - 06.2008
Bachelor of Science - Pharmacy
Cairo University, College of Pharmacy
09.1994 - 07.1999
Foot ball, Athletics
· Best sport spirit award in riva pharma football competition.
. Participating in Maadi Club Marathon competition.
Foot ball, Athletics
· Best sport spirit award in riva pharma football competition.
. Participating in Maadi Club Marathon competition.
Reference persons
Dr. Gamal Elleithy
CEO at Future pharmaceutical industries
Mr. David Olafson
Head of global clinical team at HIKMA.
Dr. Hasan Disi
Head of branded product development at HIKMA (Previous).
Foot ball, Athletics
· Best sport spirit award in riva pharma football competition.
. Participating in Maadi Club Marathon competition.
References
Dr. Hasan Disi
Head of research and development for MENA at HIKMA (Previous)
Mr. Khalid Alhasson
CEO at Sudair Pharma
Dr. Gamal Elleithy
CEO at Future Pharmaceutical Industries
Mr. David Olafson
Head of global clinical studies at HIKMA.
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