Ali Isfahani

P.O. Box ******

North Richland Hills, Tx 76182

Phone: (858) - 722-3024

Email: ad30o8@r.postjobfree.com

EXPERIENCE

Principal Scientist, Nov 2016 thru Present

Monarch Pharmaceutical, Fort Worth Tx 76187

Responsible for formulation of liquid, semi-solid and solid dosage drug, process development and monitoring of new drug, development and manufacturing processes for drug products, assisting in the review and approval of master batch records and transferring formulation technologies to support process development, scaled-up and cGMP manufacturing. Successfully Launch over fifty OTCs and ANDA in Market.

Performed analytical method development, validation and transfer to QC department, provided analytical support for preformulation/formulation, stability study to generate testing in support of ANDA and OTC.

Maintaining GXP Work environment and documentations as per companies’ SOP and Policies and Compliance with guidelines from regulatory agencies like FDA, ICH. Working as per QbD Guidelines. Responsible for successful technology transfers and product launches.

Equipment utilized included: HPLC, UPLC, GC, LC-MS, ICP-MS, GC-MS Particle Size Analyzer, and different process and formulation equipment under GMP environment.

Senior Scientist, Sep 2012 thru Oct 2016

Qualitest Pharmaceuticals, Huntsville, Al 35814

Performed analytical method development, validation and pharmaceutical analysis of API, finish product, trace impurities, degradation and characterization of drug substances.

Responsible for special investigations as needed to solve analytical, formulation and regulatory issues to generate data in support of IND and writing of CMC sections.

Proactively identified potential issues and developed creative solutions to technical problems in order to keep projects on schedule.

Author protocols and statistical reports to evaluate analytical method for transfer to internal group, CRO and CMO. Manage, designed and implement stability program. Assisted and maintained stability program on oral solution and solid dosage form.

Performed evaluation and implementation of new analytical technologies, setting specification and special projects.

Provide technical support for formulation of liquid, solid dosage drug, process development and monitoring of new drug, development and manufacturing processes for drug products, assisting in the review and approval batch records and transferring formulation technologies to support process development, scaled-up and cGMP manufacturing.

Equipment utilized included: UPLC, HPLC, GC, GC/MS, LC/MS/MS, ICP-MS, CE, FTIR, NIR, and different process and formulation equipment GLP/GMP environment.

Principal Scientist, Jan 2009 thru Aug 2012

Duker Pharmaceuticals, Addison, TX 75074

Conducted analytical method development, designed and executed formulation development programs in pharmaceutical Semi Solid and liquids dosage forms, including both immediate release and controlled release products. Responsibilities include conducting pre-formulation studies, formulation development works, and in-process physical testing.

Managed and coordinate the activities of a team of scientist within the analytical and formulation development group. Provided strategic, scientific and managerial leadership in the formulation development department set project goals, timelines and resource requirements.

Managed product development activities, assign projects to appropriate teams and provide direction to solve complex drug development issues.

Responsible for analytical method development, validation and transfer to QC department, provided bioanalytical support for preformulation/formulation, stability study to generate testing in support of IND and writing of CMC sections.

Provided technical support for addressing cGMP scale-up and process development issues including critical process parameter (CPP) assessments, technology transfer to partner CMOs, validation, submission batches & other CMC related activities.

Responsible for the purchase of capital budget items (service contracts, formulation and analytical equipment’s, etc.).

Equipment utilized included: HPLC, UPLC, GC, LC/MS/MS, ICP-MS, FTIR, NIR and different process and formulation equipment in GLP/GMP environment.

Ali Isfahani

Senior Scientist, Nov 2004 thru Dec 2008

Leiner Pharmaceutical, Charlotte, NC

Responsible for formulation of sustained-release, solid dosage drug, process development and monitoring of new drug, development and manufacturing processes for drug products, assisting in the review and approval of master batch records and transferring formulation technologies to support process development, scaled-up and cGMP manufacturing.

Performed analytical method development, validation and pharmaceutical analysis of API, finish product, trace impurities, degradation and characterization of drug substances.

Directed the activities and management of analytical development and chemistry-related activities for new product and stability study. Conducted special investigations as needed to solve analytical, formulation and regulatory issues to generate data in support of IND and writing of CMC sections. Developed, designed and implement stability program. Provided technical support to manufacturing, formulation department and supervised 4 chemists within formulation and analytical groups.

Equipment utilized included: HPLC, GC, LC/MS/MS, ICP-MS, CE, FTIR and different process and formulation equipment.

Staff Research Associate, Jan 2001 thru Sep 2004

Skye Pharma; San Diego, CA 92121

Performed formulation and analytical method development, validation and pharmaceutical analysis of finish product, trace impurities.

Provided method development and analytical support for testing of protein, lipid –and-polymer-base sustained-release pharmaceutical formulation for drug delivery technologies in GMP/GLP environment.

Responsible for developing and validating Bioanalytical methods for drug substance and metabolites (small organic molecule) in support of clinical pharmacokinetics and toxicology studies using high throughput solid phase extraction

and liquid extraction in conjunction with LC/MS/MS.

Provided analytical support for process monitoring in support of clinical study as dictated by CBER. Created Validation, qualification protocols, statistical reports to evaluate analytical method and assays for transfer to QC, process development and manufacturing.

Equipment Utilized: HPLC, GC, IC, LC/MS/MS, CE and Solid Phase Extraction.

Scientist II, Feb 98 thru Dec.00

Tridad; San Diego, CA 92121

Performed method development, validation including characterization, Sequencing, formulation and structure elucidation of nucleic acid-based products and pharmaceutical analysis of finish product, trace impurities, degradation and oligonucleotide in GMP environment. Conducted analysis of products used in the testing and regulatory submission requirements for IND/NDA stage as dictated by CDER.

Responsible for organizing and managing day to day laboratory activities (supervised 4 chemists) and for reviewing, generating SOPs and data analysis/statistics report.

Performed evaluation and implementation of new analytical technologies, setting specification and special projects and managing reference standard program.

Provided leadership to individuals and cross-functional teams. Mentored junior level scientists and analysts technically, professionally and interpersonally in order to develop their decision-making skills, confidence, technical competence, and judgment.

Equipment Utilized: HPLC, Ion Chromatography, FTIR, GC, UV/Vis, MALDI-TOF, GCMS, ICP and LC/MS GLP/GMP environment.

Lead Chemist- - Mar. 93 thru Jan. 98

Merck Research Laboratories; West Point, PA 19486

Conducted research and method development, Optimization and validation of assay for characterization formulation, and quantitative analysis of Bacteria, Viral and DNA vaccine products in supports of Bioprocess. Performed assays development, analysis, purification, characterization and sizing of Polysaccharide, Protein, Oligonucleotide, and their derivatives and polymeric compound for various vaccine products and organic synthesis in compliance with GLP and cGMP. Created Validation and qualification protocols, statistical and reports to evaluate assays for transfer to Process development and MMD.

Provided method development and analytical/ bioanalytical support for preformulation/formulation, stability study and to generate a chemical equivalence testing in support of IND and writing of CMC sections.

Provided analytical support for process monitoring and support of vaccine clinical study that resulted in NDA submission as dictated by CBER. Provided support, product improvement and problem solving for research, MMD and Process development. Designed experiment to predict drug stability and prepared several lots to support the new formulation. Plan and execute analytical operations utilizing principle of Design of Experiment. Equipment Utilized: HPLC, Ion Chromatography, CE, TGAMs, GCMS, NMR, LC/MS and SFC.

Ali Isfahani

Senior Scientist - Aug. 90 thru Jan. 93

Mycologix. (Boehringer Mannheim); Gaithersburg, MD 20878

Performed research and development of vaccines, by formulations, purification, characterization, sizing and depolymerization of polysaccharide, protein and conjugation processes for use in the MEP, Meningococcal, Haemophilus influenza disease project.

Conducted research involving development, optimization, formulation of lab scale fermentation and seed stability study and microbiological support.

Responsible for upstream processes development and improvement through the use of different filtration units under cGMP condition and transfer to pilot plant and Manufacturing.

Responsible for the development, scale up and technical transfer of formulations and manufacturing processes between lab scale, GMP pilot plant and manufacturing facilities.

Provided technical support to manufacturing department and supervised 2 chemists within in-process and analytical groups.

Conducted multi-step organic synthesis, isolation and identification of organic molecules. Method development and validation for the characterization and quantification of drug levels from biological tissues and enzymatic assays. These assays involve kinetic analysis techniques on experimental animal. Studied Optimization and scale-up effect of oxygen and heating on biochemical characterization in fermentor for manufacturing.

Responsible for organizing and managing day to day laboratory activities and for reviewing, generating SOPs, batch records and production of vaccine clinical Lots.

Responsible for the study of bimolecular interactions in understanding processes of molecular recognition and biological function by utilizing BIA Core.

Equipment utilized included: HPLC, GC, FPLC, IR, AA, CE, NMR, SDS-Page, Gel Electrophoresis, column chromatography, LC-MS, ELISA, UV-VIS, Molecular sizing, Filtration Units, Fermentor. and radioisotope material.

Pharmacy Scientist - Aug. 86 thru Jun. 90.

United States Army; Ft. Devens / Natick Research Laboratory, Natick, MA 02112

Research included investigation into the mechanism of DNA, RNA synthesis and Sequencing, as well as hormone therapy, cellular change in molecular dynamics, and non-invasive magnetic resonance studies of cellular damage in humans and lower animals. Responsible for protein purification and measuring levels of oxidative damage in DNA, protein, and lipids, oxidative stress state at molecular and cellular level, and enzyme assays on animals of different ages.

Research also was conducted on how the spin-trap drug affects the damage levels as a free radical scavenger and wound healing. Performed multistep synthesis, isolation, purification and structural determination of organic material for use in formulation of neurological agent. Responsible for development study in-life portions of drug metabolism, bio transformation and bioanalytical studies in animal. Responsible for organizing and managing laboratory activities and supervising 3 chemists within the group.

Conducted Formulations consisting of small molecule, dose preparations, study and determination of specific activity of drug delivery system, manipulation of test species, and maintenance of test species and collection of sample matrices.

Responsible for Preparation, purification and characterization of organic, polymeric compounds for biological evaluation in animal study.

Routinely worked with GC/MS, GC, CE, HPLC-MS, AA, ICP, HPLC, UV-VIS, ELISA, Northern & Southern blotting Gel filtration, Affinity and Ion Exchange chromatography.

Senior Chemist (Medicinal Chemist)- Feb. 84 thru July. 86

Pfizer Pharmaceutical; Dallas, TX 75083

Conducted research involving the synthesis, characterization and evaluation of organic and polymeric materials for use in the therapeutic drugs.

Responsible for carrying out multi-step synthesis of organic molecules and optimization existing synthetic routes and scale-up from lab(mg) to pilot- plant (g) scale.

Performed bioanalytical quantitative assays for small molecule drug candidates in biological matrices to support discovery, PK, PD and toxicology studies. Formulation of pharmaceutical products in dosage forms included solid oral, semisolid topical.

Responsible for characterization and quantitative analysis of finished product, trace impurities and pharmaceutical formulation. Responsible for development, characterization and formulation of new molecules in sustained-release, solid dosage and liquid forms. Routinely used HPLC, GC, TLC, AA, HPLC-MS, ICP, FT-IR, NMR and Ion exchange, Hydrophobic Interaction, Affinity chromatography. Also became familiar with GLP and GMP regulations.

Ali Isfahani

Chemist -May. 80 thru June. 83

Department of Chemistry; Kent State University, Kent, OH 20783

Research, development, and laboratory work done on the synthesis and purification of n-hexyl-3-hydroxy-4'-n pentyloxy biphenyl-4-carboxyacid. Responsible for utilizing laboratory equipment such as the NMR, GC, HPLC, mass spectrometry, atomic absorption and atomic emission.

Computer and Software

Analysis and Graphics: Excel, Quattro Pro, Harvard Graphics, Statgraphics, StatMost, Cricket Graph and DOE.

Selected Awards from the United States Army

Army Achievement Medal Army Good Conduct Medal Army Commendation Medal

Personal

American Veteran & American Citizen

Professional Affiliations

The Planetary Society The American Chemical Society The Society For Applied Spectroscopy

Education

Bachelor of Science: Major: Chemistry, Completed: August 1984 University of Texas at Dallas, Richardson TX

1987 - 1990 Worked Toward Graduate Degree Major: Analytical Chemistry University of Lowell, Lowell

MA

References available upon request

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