Research And Development Head
Med City Pharma
Total years of experience :14 years, 9 Months
• Lead Product development, technology transfer and product launches of (Solid, Liquid, semisolid) dosage forms.
• Expert in pharmaceutical small molecule product development of both formulation and analytical research.
• Effective product development using Quality by Design (QbD) approach.
• Effective technical & operational trouble shooting during manufacturing.
• Product life cycle management through maintaining state of control & facilitate continual improvement.
• Lead Product development, technology transfer and product launches of (Solid, Liquid, semisolid) dosage forms.
• Expert in pharmaceutical small molecule product development of both formulation and analytical research.
• Effective product development using Quality by Design (QbD) approach.
• Effective technical & operational trouble shooting during manufacturing.
• Product life cycle management through maintaining state of control & facilitate continual improvement.
• Lead Product development, technology transfer and product launches of (Solid, Liquid, semisolid) dosage forms.
• Expert in pharmaceutical small molecule product development of both formulation and analytical research.
• Effective product development using Quality by Design (QbD) approach.
• Effective technical & operational trouble shooting during manufacturing.
• Product life cycle management through maintaining state of control & facilitate continual improvement.
1- Literature survey including:
( Brand Patent status - API physical, chemical & biological properties - Brand excipients grades - Brand manufacturing process - Brand pharmacokinetics -
In-vivo, In-vitro assessment - manufacturing feasibility - packaging suitability - EHS requirements - bioequivalence & bio-waiver requirements) .
2- Pre-Formulation studies including:
API characterization - API & Excipient compatibility testing using DSC, HPLC -compressibility testing - de-formulation by DSC .
3- Formulation development using different techniques
( direct compression - wet granulation- spray granulation- solid dispersion - layering - dry granulation - compaction - slugging - capsules filling - emulsion - suspension - syrup - cream - gel )
4- Follow up the stock of API & Excipients in the lab.
5- Prepare SOPs & ensure technical & quality aspects.
6- Follow up the requirements for the registration of new products.
7 Prepare Master formula, Process Validation protocol and Development protocol & report
8- Determine suitable primary & secondary packaging tools for new products.
9- Implement QbD in product development .
- Characterization of Brand, API, Excipients
- Conduct excipients compatibility study and exipient grade selection.
- Initial risk assessment of ( excipient, formulation, intermediate material & parameter ) variables.
- Make (DOE) Design of experiment for high risk variables using Design-Expert® Software.
- Data analysis and significant factors’ range prediction to ensure the (QTPP) Quality target product profile.
- Update the risk assessment of the (CQAs) critical quality attributes.
- Make scaling up strategy from lab to pilot & commercial scales.
- Establish control strategy for the high risk CQAs for the commercial manufacture.
1- Analysis of R&D formulation samples of different forms
Using different types of HPLC (Alliance-Breeze-shimadzu), ACQUITY Uplc Waters, GC, UV spectroscopy apparatuses & Titration Methods.
2- Formulate & Develop the formulation process of different forms of pharmaceutical products .
3- Identify Ingredient dependent issues within formulation & processes .
4- Provide scientific, technical and operational support of drug product development.
5- Stability & Methodology :
A) - Analysis of stability samples including their related substances .
B) - Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products.
C) - Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity.
6- Making Validation of the Analytical Methods .
7- Establish & develop new analytical methods for analysis of different forms Of pharmaceutical preparations.
8- Making Biowaiver Studies according to FDA Guidance .
9- Management of of Trouble shooting in different apparatuses with time planning schedule.
10- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP.
11- preparing different types of testing & volumetric solutions and adjust the requires factors according to USP.
1- Participate in the start up of the lab .
2- Analysis of QC Finished & Raw material of different forms
Using different types of HPLC (Alliance-Breeze-shimadzu), ACQUITY Uplc Waters, GC, UV spectroscopy apparatuses & Titration Methods.
3- Formulate & Develop the formulation process of different forms of pharmaceutical products .
4- Identify Ingredient dependent issues within formulation & processes .
5- Provide scientific, technical and operational support of drug product development.
6- Stability & Methodology :
A) - Analysis of stability samples including their related substances .
B) - Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products.
C) - Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity.
7- Making Validation of the Analytical Methods .
8- Establish & develop new analytical methods for analysis of different forms Of pharmaceutical preparations.
9- Making Biowaiver Studies according to FDA Guidance .
10- Management of of Trouble shooting in different apparatuses with time planning schedule.
11- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP.
12- preparing different types of testing & volumetric solutions and adjust the requires factors according to USP.
1- Analysis of R&D Formulation & Stability samples of different forms
Using different types of HPLC (Alliance-Breeze-shimadzu), ACQUITY Uplc Waters, GC, UV spectroscopy apparatuses & Titration Methods.
2- Stability & Methodology :
A) - Analysis of stability samples including their related substances .
B) - Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products.
C) - Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity.
3- Making Validation of the Analytical Methods .
4- Establish & develop new analytical methods for analysis of different forms Of pharmaceutical preparations.
5- Making Biowaiver Studies according to FDA Guidance .
6- Management of of Trouble shooting in different apparatuses with time planning schedule.
7- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP.
8- preparing different types of testing & volumetric solutions and adjust the requires factors according to USP.
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