MINA FAYEZ GHATTAS
R&D Manager
Cairo,Cairo
Summary
Results-driven management professional with proven ability to lead teams to success. Strong focus on team collaboration, operational efficiency, and achieving measurable outcomes. Adept at strategic planning, process improvement, and fostering culture of accountability and excellence. Known for adaptability and consistently meeting changing organizational needs.
Overview
16
16
years of professional experience
2018
2018
years of post-secondary education
Work History
Manager, Research and Development Department
Kirovest Pharmaceuticals
Obour City, Cairo
12.2019 - Current
- Review and execution of all documents and SOPs of R&D Department
- Set annual R&D department objectives and budget with follow up plan through the whole year
- Setup and Implementation of training program and qualification of department staff
- Accomplish all MOH requirements for registration which enhance portfolio of Kirovest Pharmaceuticals
- Setup Development plan for new products and existing products (Successfully managed to participate of production of more than 25 product within 2023-2024)
- Follow up the all activities within the Formulation lab
- Review analysis data to establish scientific based decision on the development of products
- Review and execution of Process validation protocols and reports
- Review and approve Master Formula and Finished product specifications of products under development
- Review and approve of Batch Manufacturing Records and Batch Packaging Records
- Review results from performed experimental trials and give opinion for further proceeding
- Supervise the execution of Pilot Batches and Validation Batches required for registration purposes
- Contact with Suppliers for setting up the requirement and Specification of API and excipients
- Follow up the calibration and qualification plan for laboratory equipment and machines
- Review and Approve Method of analysis, validation protocol and report, stability protocol and report
- Prepare NODCAR File for new products batch submission
- Prepare CTD file required for some products registration
- Supervise the analytical method development activities
- Review HPLC qualification and calibration protocols and reports
- Dealing with third party agencies responsible for the supply of Reagents, spares and Brand products
- Dealing with BE centers for the conducting studies required for new product registration
Deputy Manager, Research and Development Department
Pharmed Health Care
04.2016 - 11.2019
- Responsible for compliance with cGMP and regulatory requirements
- Responsible for maintenance of quality policy
- Responsible for compliance with system SOPs
- Responsible for participation in Internal Audits / Self Inspection
- Manage the budget of R&D projects under her/his responsibilities
- Responsible to execute any responsibility as and when assigned by Plant General Manager
- Supervise the development of designated experimental trials with an ability to design an effective series of experiments and validation of method development
- Provide supportive measures that indicate the success and performance of the developed formulation and its process
- Review results from performed experimental trials and give opinion for further proceeding
- Supervising the trial batch study of the sample supplied by the vendor as an activity of vendor qualification process
- Performing or supervising Pilot batches and share in Bio wavier, Bio equivalence and all related studies with QA/QC/PD departments
- Preparation and Review of Master Formula Card (MFC) and Master Packaging Card (MPC)
- Reviewing of Batch Manufacturing Records, Batch Packaging Records and Validation Protocols
- Improvement of already formulated products when dictated
- Ensuring that Scaling-up to production sections is successful
- Ensuring that Trouble-shooting in production, if any, is handled effectively
- Determining requirements and specifications of R&D APIs and Excipients
- Determining and approval of punches designs
- Ensuring that Comparing different formulation, for the same pharmaceutical product, during the pharmaceutical products development and upon storage, is performed to choose the proper formulation for each pharmaceutical product
- Effective participation in Handling of Deviations, Incidents, Corrective and Preventive Action (CAPA) and failure investigation as and when applicable
- Preparation and review of Research and Development SOPs
- Supervision of maintenance tasks of laboratory instruments and equipment including working instructions manuals & records, logbooks, calibrations and preventive maintenance requirements
- Transferring information about raw materials, packaging materials, inprocess products, finished products stability and miscellaneous materials to Quality Control
- Monitoring with QA and Production representatives Technology Transfer process
- Supervision of the three consecutive validation production batches which shall be executed
- Reviewing and Certification of Validation report in share with Head Production and Head QA
- Operation and Coordination of Calibration of Research and Development Instruments
- Development of employees assigned to his department, ensuring the correct application of tools and policies on training, career path and evaluations
Senior Specialist, Research and Development Department
Global Napi Pharmaceuticals (GNP)
09.2015 - 04.2016
- In addition to the daily tasks of R&D Officer
- Writing and reviewing laboratory instruments and Lab Procedures SOPs according to GMP Guidelines
- Training and supervising newly hired R&D generalist officers operating different Lab instruments
Formulation officer in Research and Development Department
Global Napi Pharmaceuticals (GNP)
04.2010 - 08.2015
- Identifying ingredient-dependant issues within formulation and processes
- Researching and collecting the necessary literature for incompatibilities, bio-availability and all other regulatory requirements
- Assisting in troubleshooting and overcoming production problems to enable smooth transfer of new products into production
- Ensuring the implementation of current Good Manufacturing Processes (cGMP) as well as other set standards to ensure compliance with regulatory requirements
- Reporting & summarizing results of experimental trials and other data into a format that allows easy review by superiors
- Maintaining laboratory instruments and equipment and demonstrate an understanding of operational hazards
- Participating in transforming R&D Product Development efforts into scalable manufacturing processes and robust and quality products
Pharmacist
Maher's pharmacy
Cairo, Cairo Governorate
07.2009 - 04.2010
- Dispensing prescription medicines
- Selling over-the-counter medicines
- Performing patient counseling
- Ensuring that different treatments are compatible
- Keeping a register of controlled drugs for legal and stock control purpose
- Advising patients of any adverse side-effects of medicines or potential interactions
- Managing and training pharmacy support staff
- Budgeting and financial management
- Arranging the delivery of prescription medicines to patients
Education
B.Sc. of Pharmacy - Pharmaceutical Sciences
Modern Science And Arts University (MSA)
09.2005 - 01.2009
B.Sc. of Pharmaceutical science -
Greenwich University
United Kingdom 04.2001 - 01.2010
General secondary certificate -
Patriarchal College Language School
CairoSkills
- Microsoft Office
- Windows
- Word
- Excel
- Access
- PowerPoint
- Outlook
Minitab
- Photoshop
Military Status
Exempted
Personal Information
- Date of Birth: 10/12/86
- Gender: Male
- Nationality: Egyptian
- Driving License: Valid till 2024
- Marital Status: Married
Training
- Student Skills Development Program (SSDP), Recruitment and Training Committee (RTC) Faculty of Pharmacy, Cairo University, 11/01/06 to 12/01/06
- Summer Training, Global Napi Pharmaceuticals (GNP), 08/27/07 to 08/30/07
- Summer Training, Global Napi Pharmaceuticals (GNP), 08/27/08 to 08/30/08
- Workshop on Tablets of Capsules Manufacturing QC, QA Challenges, El Mehy Engineering Company, 10/11/11 to 10/12/11
- Future University International Workshop on Modern Tablet Manufacturing, 02/20/13 to 02/21/13
Timeline
Manager, Research and Development Department
Kirovest Pharmaceuticals
12.2019 - Current
Deputy Manager, Research and Development Department
Pharmed Health Care
04.2016 - 11.2019
Senior Specialist, Research and Development Department
Global Napi Pharmaceuticals (GNP)
09.2015 - 04.2016
Formulation officer in Research and Development Department
Global Napi Pharmaceuticals (GNP)
04.2010 - 08.2015
Pharmacist
Maher's pharmacy
07.2009 - 04.2010
B.Sc. of Pharmacy - Pharmaceutical Sciences
Modern Science And Arts University (MSA)
09.2005 - 01.2009
B.Sc. of Pharmaceutical science -
Greenwich University
04.2001 - 01.2010
General secondary certificate -
Patriarchal College Language School
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