Mahnaz Yazdani
Ph.D. in BIOCHEMISTRY, adcszy@r.postjobfree.com
PROFILE
Comprohensive exprerince as Research and Development of Drug
Thorough understanding of Health Canada and FDA regulation, Canadian Pharmacuetical Law and Administration,as well as GMP, GLP and GCP guidances.
Extensive hands-on experience of a wide range of Microbiological (Isolation and characterization of a wide variety of microbial strains), biochemical and proteomic techniques, as well as a strong theoretical background.
Experienced in various biophysical techniques in protein structure, ligand interaction characterization, spectroscopy included UV.
Experienced in detailed proteomic which involved the use of 2D gel electrophoresis and was performed in collaboration with scientists at the Pasteur Institute.
Familiar with methods protein extraction; SDS-PAGE; immunoblotting; affinity purification; enzyme purification and assays; protein biochemistry; molecular biology, etc.,
Experienced in developing analytical methods to monitor and characterize target product purity and integrity (e.g., HPLC, Western blotting, ELISA, protein quantification,PCR) for Rodent/Rat blood samples.
Strong computer skills and data analysis and experience creating and interpreting phylogenic trees
Repeatedly shown willingness and enthusiasm to learn new methods in the pursuit of a research goal.
PROFESSIONAL EXPERIENCE
Research and Development Scientist ( September. 2018 –2020)
Toronto Institute of Pharmaceutical and Technology,Toronto
Research Associte & Instructor ( September. 2016 –2018)
Toronto Institute of Pharmaceutical and Technology,Toronto
Provided scientific, production, formulation/process development support and analytical testing support for the R&D depertment and commercial projects in accordance with SOP,GMP,TIPT policies and regulatory requirments.
Assisted in the investigation of process deficiencies of existing formulations to determine the cause
Monitored chemical reaction in various projects by utilizing HPLC methods
Communicated formulation objectives with members of the Analytical Development Team
Performed sampling and analysing of raw materials, In-process and finished product (Solid Dosage form, Liquid, Imulsion,Suspention,Cream,Gel,Nazal spray)
Carried out analytical testing including Identification, Assay(employing Waters HPLC with Empower software and UV/VIS), Uniformity of Dosage Units, Dissolution(Type I, II), Disintegration, Hardness, Friability, titration by Karl Fisher, Powder characterization and other tests
Conducted batch manufacturing followed by manufacturing processes
Prepared SOPs for all equipment and processes, filled all logbook, batch folder and document in compliance with GMP guidelines, calculated process Yield and Reconciliation
Performed formulation development,Design of experiments, optimization of immediate release and controlled release technologies of Caffeine in a GMP/GLP environment
Performed Bioburden,Microbial Culturing,Enumeration, Aseptic technique and Sterilization
Wrote protocols and reports for assigned projects and employed statistical analysis tools such as ANOVA and Regression, Design Expert7.0 Sofware(Biostatistics)
Empower Software(HPLC)
MS office
EDUCATION:
Research &Development of Drug Diploma (Sep. 2015 - Sep. 2016) Toronto Institute of Pharmaceutical and Technology
Ph.D. in Biochemistry,Tarbiat Modares University, Tehran, Iran (Sep.2004 - Nov.2008)
M.Sc. in Biochemistry, Tarbiat Modares University, Tehran, Iran (Sep.1996-July.1999)
B.Sc. Biology,Shiraz University,Shiraz,Iran (Sep.1990-July.1994)