Ismail Mathakiya Email & Phone Number

Saudi Arabia

Al Qasim, Saudi Arabia

Ph.D. in Chemistry with more than 21 years of comprehensive work experiences in pharmaceutical Analytical Science, Regularoty Affairs, Quality Control, cGMP Compliance and QMS.Proven track record of successfully leading supervisors & training analytical scientists/QC chemists. • Excellent work experienced in analytical method development, method validation and technology transfer in compliance with requirements of SaudiFDA, ICH, US-FDA, EMEA & other regulatory agencies. • Extensive… Show more Ph.D. in Chemistry with more than 21 years of comprehensive work experiences in pharmaceutical Analytical Science, Regularoty Affairs, Quality Control, cGMP Compliance and QMS.Proven track record of successfully leading supervisors & training analytical scientists/QC chemists. • Excellent work experienced in analytical method development, method validation and technology transfer in compliance with requirements of SaudiFDA, ICH, US-FDA, EMEA & other regulatory agencies. • Extensive experience to worked with well know licensors/innovators • Outstanding verbal and written communication skills with track record of positive attitude. • Managed R&D and QC laboratory operations to assure timely released of materials and products• Demonstrated excellent strength in fit-for-purpose method development for testing of new drug substances, pre-formulation, formulation development, stability study. • Hands on experience of new materials/formula characterization using instruments such as HPLC, UPLC, GPC, Gas Chromatography, FTIR, ICP-OES, AAS, and UV-VIS spectroscopy, DSC, TGA, TOC, KF, PSA, Viscometers, Polarimeter and Microscopy. • Interpretation skills of 1H- and 13C-NMR, LCMS, XRD, SEM, elemental analysis data pertaining to characterization drug substances . • Established ability to strategize, reviewed and approved CMC documents eCTD files for new products regulatory submissions handled queries and faced audits by Benchmark Regulatory Agencies and top global pharmaceutical companies. • Managed and handled multiple projects concurrently and set priorities in conjunction with senior management in a fast-changing, results-oriented R & D environment. Ensure that specific objectives/goals are met. • Trained on various SAP (System Application Practice) functionality like product development and stability modules, Easy DMS, Docubridge and quality modules. Show less

Established the QC Chemical & Microbiology laboratories at TPMC, Dammam project and successfully received cGMP accreditation by Saudi FDA.Reviewed the new lab design, prepared URS and made necessary amendments for setting-up a new regulatory compliant laboratory. Evaluated services/utilities requirement for MEP system in the QC lab and ensured its proper configuration & implementation by coordinating with project/engineering team. Developed SOPs for instruments, lab… Show more Established the QC Chemical & Microbiology laboratories at TPMC, Dammam project and successfully received cGMP accreditation by Saudi FDA.Reviewed the new lab design, prepared URS and made necessary amendments for setting-up a new regulatory compliant laboratory. Evaluated services/utilities requirement for MEP system in the QC lab and ensured its proper configuration & implementation by coordinating with project/engineering team. Developed SOPs for instruments, lab activities/processes and established good laboratory practices.Prepared, reviewed and approved the study protocols for qualification activities such as water plant, compressed gases, cleanrooms qualification, manufacturing machine qualification etc.Provided complete and on time lab support to qualify the plant utilities and facilities.Successfully completed testing technology transfer for more than 25 products in various dosage forms from R & D to Dammam plant QC lab. Managed QC laboratory operations to assure timely released of materials, in-process and finished products with required quality standards are meets.Monitored the stability study program for pilots and process validation batches. Reviewed and approved all laboratory reports, methods and procedures for lab use.Developed quality system for handling of deviation, change controls, Alert / Action / OOS / OOT reporting and CAPA preparation.Developed and maintained proactive communication with cross functional departments to meet quality standards by anticipating customers/licensors/ regulatory expectations. Established and maintained systems, policies and procedures to ensure product quality and compliance meet in accordance to GMP and other key regulatory standards.Ensured laboratory operations meet business and customer needs by clearly communicating resource and state-of-the-art instrumentation needs to top management. Identified all lab requirements (Instruments, manpower, chemicals, standards, consumables, Microbiological media, Show less

New York

Member of Analytical R & D devision and leading a team of Analytical Scientists / Research fellows who are responsible for development of quality generic pharmaceutical for US Market. Responsible for method development, method validation, CMC dossier preparation and analytical technology transfer.

Al Qassim

•Successfully completed 3 Human Insulin inj. formulations dev. project including tech. dossier submission in eCTD format and submission to SFDA, KSA. •Achieved credentials in formulation & analytical method dev. for more than 30 in-house formulated products of different dosage forms & successfully registered with MOH.• Liaison and lead the SPIMACO technical team for Eli Lilly (Licensor) products and successfully registered 8 new generation Lilly products with MOH… Show more •Successfully completed 3 Human Insulin inj. formulations dev. project including tech. dossier submission in eCTD format and submission to SFDA, KSA. •Achieved credentials in formulation & analytical method dev. for more than 30 in-house formulated products of different dosage forms & successfully registered with MOH.• Liaison and lead the SPIMACO technical team for Eli Lilly (Licensor) products and successfully registered 8 new generation Lilly products with MOH, KSA.•Completed technical evaluation of licensors Schering Plough & SMB, Belgium know-how Files for 5 products and successfully registered with Saudi MOH.•Member of SPIMACO tech team involved on tech-transfer from licensor Kyorin Pharma, Japan •Successfully completed 2 solid oral products registration activities for EU marketing approval.•Successfully completed method development, validation, document preparation, product registration (Local and Export) activities for more than 75 products.•Trained on various SAP functionality Show less

Worked on ANDA PROJECT and successfully developed TEN injection formulation and TWO solid oral products for ANDA submission and from them SIX products already received USFDA approval and other are in the advance stage of approval.Worked in a Peptide Formulation team who developed controlled releases once a month (DEPOT) injectable anticancer microencapsulated formulation systems and become first in India to launch the same in its kind.Developed several Biodegradable polymers for… Show more Worked on ANDA PROJECT and successfully developed TEN injection formulation and TWO solid oral products for ANDA submission and from them SIX products already received USFDA approval and other are in the advance stage of approval.Worked in a Peptide Formulation team who developed controlled releases once a month (DEPOT) injectable anticancer microencapsulated formulation systems and become first in India to launch the same in its kind.Developed several Biodegradable polymers for controlled release formulation study. Show less

Ph.D., Preparation And Properties Of Biodegradable Copolymers

Activities and Societies: Design, development and optimization of synthesis process for tartaric acid based polyamides. Characterization.

B., B. Sc., M.Sc. (Chemistry)

Study in Basic science and chemistry