Bikash Mondal, Ph.D. Email and Phone Number
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Ph.D. Chemist with over 12 years of industry experience leading analytical R&D for several NDA/ANDA submission, and NCE (New Chemical Compound) discovery research, Process & Product development, and Quality Control.Well versed in global regulatory requirements, Quality, Compliance, cGxPs for Product Development and Manufacturing. HIGHLIGHTS:• Authored and reviewed the CMC section for submission to regulatory agencies.• Mentored and managed junior chemists/scientists on daily basis and oversaw CROs for various projects.• Provided analytical support for product development, including complex [polymeric microspheres and lipid nanoparticle (LNP)] formulations of small molecules and peptides in cGMP/GLP environment.• Developed analytical test methods using HPLC, UPLC, GPC (SEC) coupled with various detectors such as CAD, UV, MS, PDA, and RI. • Synthesized bioconjugates (protein/antibody-drug/dye) for drug delivery/imaging and characterized it using NIR, MALDI-ToF, FPLC (SEC) and UV-Vis Spectroscopy.• Identified and elucidated structure of new chemical compounds (including small molecules) and unknown impurity using HPLC, NMR (including 2D NMR), LCMS, GCMS, and FTIR. • Developed analytical test methods using HPLC, UPLC, GPC (SEC) coupled to various detectors such as CAD, UV, PDA, and RI. • Developed and optimized methods for particle size analysis (Laser diffraction and DLS), Zeta Potential, rheology (viscosity), osmolality, dissolution (IVRT) study, stability test, and Impurity analysis.• Characterized Solid-State Material using TGA and DSC, Raman, FTIR (ATR), XRD, SEM (EDS), TEM, AFM, light and confocal microscopy, and contact angle goniometry. • Accomplished extensive chromatographic separations and developed methods for purity checking of new molecules (including chiral molecules) by HPLC and preparative HPLC.• Applied Quality by Design (QbD) approach, Design of experiment (DoE) study, and statistical tools (JMP) for analytical method development.• Validated analytical methods and prepared its reports; Method transfer to manufacturing site and CRO/CDMO• Prepared analytical reports and protocols; analyzed data and presented data in group meetings.• Maintained thorough and complete documentation in Electronic Note (ELN) book and Laboratory Information Management System (LIMS).
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Principal ScientistHikma Pharmaceuticals Jan 2024 - PresentLondon, London, Gb -
Senior ScientistHikma Pharmaceuticals May 2022 - Jan 2024London, London, Gb -
Scientist Iii-R&DHikma Pharmaceuticals Jun 2020 - Jun 2022London, London, Gb -
Senior Scientist-Analytical R&DAkorn, Inc Mar 2019 - Jun 2020Lake Forest, Il, Us -
Analytical Scientist-R&DAkorn, Inc Dec 2016 - Mar 2019Lake Forest, Il, Us -
Scientist-Analytical R&DTeva Pharmaceuticals Oct 2015 - Oct 2016Tel-Aviv, Il• Provided analytical support to product development including complex (polymeric and liposome based) formulations of small molecules and peptides in cGMP/GLP environment• Developed analytical test methods using HPLC, UPLC, GPC(SEC) coupled to various detectors such as CAD, UV, PDA, and RI • Developed and optimized methods for particle size analysis, rheology (viscosity), dissolution (IVR) study, stability test, and Impurity analysis• Applied Quality by Design (QbD) approach, DOE study, and data analysis using statistical tools for analytical method development• Validated analytical methods and prepared its reports; Method Transfer• Prepared analytical reports and protocols; Analyzed data and presented data in group meetings • Managed data in Laboratory Information Management System (LIMS) and documentation in Electronic Note (ELN) book• Well-versed in USP, GMP, FDA, and ICH regulatory guidelines -
Research Assistant And Adjunct LecturerCity University Of New York Jul 2015 - Jan 2016New York, Ny, Us•Modified polymeric surfaces to reduce protein adsorption•Teaching organic chemistry I lab -
Graduate Teaching AssistantCity University Of New York Aug 2010 - Dec 2015New York, Ny, Us• Taught-Organic Chemistry, General Chemistry I & II, Introduction to Chemistry, Chemistry for Today and Principles of Chemistry laboratory courses to undergraduate students• Developed curriculum and met departmental requirements• Prepared tests, graded lab report and exams -
Graduate AssistantCity University Of New York Aug 2009 - Jul 2015New York, Ny, UsThesis Advisor: Prof Alan M Lyons•Developed surface modifications processes and successfully coated silicon wafers and silica nanoparticles with different molecules to make hydrophobic and hydrophilic surfaces. •Studied the effect of surface chemistry and roughness on protein adsorption with the goal of developing highly effective, low-cost protein repellent surfaces for biomedical applications.•Investigated protein adsorption on nanoparticles and flat /superhydrophobic surfaces by confocal fluorescence microscopy, XPS, UV-Vis spectroscopy, and contact angle goniometry.•Characterized materials and surfaces using XPS, XRD, SEM (EDS), TEM, AFM, Raman, FTIR (ATR), Contact angle goniometry, TGA and DSC. •Prepared superhydrophobic polymer surfaces with excellent abrasion resistance by a simple lamination templating method for applications such as water resistant building materials, anti-icing surfaces, and various consumer products. (ACS Applied Materials & Interfaces 2011, 3, 3508-3514)..•Fabricated TiO2-polymer nanocomposite UV switchable superhydrophobic surface for photocatalytic and self-cleaning applications. (ACS Applied Materials & Interfaces 2013, 5 (18), 8915-8924).•Designed and fabricated a hybrid hydrophilic-superhydrophobic surface which exhibits sustained dropwise condensation and studied heat transfer on this surface.•Studied reliability of superhydrophobic silicone post surfaces under radiation condition (proton and gamma ray) and accelerated aging conditions (temperature, salt and DI water immersion) by FTIR, RAMAN, and contact angle measurement study•Synthesized polymer by ring opening, homo and co-polymerization techniques and characterized it by GPC, NMR, Light scattering, and FTIR.•Synthesized water soluble NIR dye (ADS832WS )/Curcumin (as a model drug)-protein/antibody/polymer (BSA, apoferritin and IgG ) conjugates •Characterized bioconjuagtes using FPLC/SEC, SDS-PAGE, MALDI-TOF, and UV-Vis Spectroscopy -
Intern-Analytical ChemistPharmax Group Inc Jul 2015 - Oct 2015• Developed and optimized methods to analyzed raw materials, formulated products and stability samples using a broad range of analytical techniques including HPLC, FTIR, UV-Vis and different wet chemistries as per USP and in-house methods• Maintained lab safety, inventory, and record keeping in GMP/GLP environment -
Graduate StudentUniversity Of Oklahoma Aug 2008 - Jun 2009• Preparation and investigation of hydration behavior of NIPAAM Hydrogel by Solid state NMR• Teaching Assistant-Organic Chemistry
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R&D Analytical ChemistChemgen Pharma International Pvt Ltd May 2006 - Jul 2008• Developed a general HPLC analysis method with 40% reduction in run time. Started automated overnight sample runs and increased productivity by 20% • Accomplished extensive chromatographic separations and developed methods for purity checking of new molecules by HPLC and Chiral HPLC• GCMS method development for purity checking and impurity profiling.• Purified compounds from complex reaction mixtures and developed chiral separation methods using preparative HPLC• Conducted structure elucidation, impurity profiling and reaction monitoring by LCMS,GCMS NMR (Including 2D NMR techniques) & FTIR• Validated methods, Maintained and checked performance of instruments, kept thorough and accurate records of the analysis, and wrote SOPs• Trained junior chemists and supervised master students for their industrial projects
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InternDey’S Medical Stores (Manufacturing) Ltd. May 2003 - Jun 2003• Performed various unit process for the manufacture of tablet, capsule, and liquid dosages form in a Good Manufacturing Practices (GMP) environment • Analyzed incoming raw materials and finished products for tablet, capsule and liquid dosages forms. • Carried-out quality control of products at the various stages of manufacturing
Bikash Mondal, Ph.D. Skills
Bikash Mondal, Ph.D. Education Details
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Graduate Center Of The City University Of New York (Cuny)Polymer Chemistry -
University Of CalcuttaPharmacetucal And Fine Chemical Technology -
University Of CalcuttaChemical Technology (Specialization In Pharmaceutical & Fine Chemical Technology) -
University Of CalcuttaPhysics & Math (Minors)
Frequently Asked Questions about Bikash Mondal, Ph.D.
What company does Bikash Mondal, Ph.D. work for?
Bikash Mondal, Ph.D. works for Hikma Pharmaceuticals
What is Bikash Mondal, Ph.D.'s role at the current company?
Bikash Mondal, Ph.D.'s current role is Principal Scientist-R&D at Hikma Pharmaceuticals.
What is Bikash Mondal, Ph.D.'s email address?
Bikash Mondal, Ph.D.'s email address is bi****@****ail.com
What is Bikash Mondal, Ph.D.'s direct phone number?
Bikash Mondal, Ph.D.'s direct phone number is +121559*****
What schools did Bikash Mondal, Ph.D. attend?
Bikash Mondal, Ph.D. attended Graduate Center Of The City University Of New York (Cuny), University Of Calcutta, University Of Calcutta, University Of Calcutta.
What are some of Bikash Mondal, Ph.D.'s interests?
Bikash Mondal, Ph.D. has interest in New Technologies, Traveling, Reading, Investing.
What skills is Bikash Mondal, Ph.D. known for?
Bikash Mondal, Ph.D. has skills like Chemistry, Spectroscopy, Uv/vis, Hplc, Ftir, Nmr, Polymer Chemistry, Tga, Organic Chemistry, Characterization, Analytical Chemistry, Uv/vis Spectroscopy.
Who are Bikash Mondal, Ph.D.'s colleagues?
Bikash Mondal, Ph.D.'s colleagues are Mohamed Hussien, Ahmad Alqaruti, Akram Salah, Mohamed Gad, Hijaze Albaba, Sumesh Chandrashekhar, Firas Bteddini.
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