Mohammad Iqbal Hossain
Dedicated and accomplished professional with 20 years of hands on experience in pharmaceutical... | Nashville, Tennessee, United States
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Mohammad Iqbal Hossain’s Emails iq****@sa****.com
Mohammad Iqbal Hossain’s Phone Numbers No phone number available.
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Mohammad Iqbal Hossain’s Location Nashville, Tennessee, United States
Mohammad Iqbal Hossain’s Expertise Dedicated and accomplished professional with 20 years of hands on experience in pharmaceutical Industry including Analytical and Formulation R&D in Liquid formulation development for ANDA submission. Extensive set of skills combined with both the formulation and Analytical R&D aspects. Specialties:Experienced in the following areas of operations: • Pre-Formulation and Formulation development for ANDA submission, Lipid based Nano suspension (LNP's). • Pharmaceutical Development Report ( PDR) , Quality by design, Risk assessment, Excipient Compatibility Studies, DOE batches, Relevant module for FDA filing , Deficiency handling, CRL responding • UPLC-H class, HPLC, GC, PSD, TOC, PDA, RI, ELSD,CAD, Zetasizer, and all other laboratory equipment • Routine QC analysis of pharma API, Excipients, Process Intermediates & formulated drug products • Waters Empower 3, Agilent chemstation, Agilent EZ chrom, Shimadzu class Vp, Shimadzu prominence, dionex & chromeleon integrated software. • Laboratory deviation & OOS investigation. • Analytical Method Development (HPLC) • Phase appropriate Analytical Method Validation for clinical studies • Analytical method validation protocol & report • Product Stability testing • Preparation of stability protocol & stability report • Laboratory equipment Calibration & Qualification including environmental chambers for stability testing. • Laboratory document preparation • Process validation/ holding time validation/ transport validation/ Freeze-thaw analysis • Cleaning validation • CAPA and Change Control handling • Extractable & Leachable (E&L) testing, RLD reverse engineering • Analytical tech transfer • Weak Product Assessment based on the frequency of OOS, OOT and the number of planned/unplanned changes over the product life cycle and remedial actions.
Mohammad Iqbal Hossain’s Current Industry August Bioservices
Mohammad
Iqbal Hossain’s Prior Industry
Novartis
|
Lannett
|
August Bioservices
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Work Experience
August Bioservices
Principal Scientist, Analytical Development ( Small Molecules)
Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Lannett
Scientist III, Validation Team, Quality Control Analytical Services
Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun May 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Lannett
Pre- Formulation Scientist
Tue Dec 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Novartis
Scientist III, AR&D
Wed May 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Dec 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Novartis
Scientist II, AR&D
Sun May 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Apr 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Novartis
Scientist I, AR&D
Tue Apr 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Novartis
Analytical Chemist, AR&D
Thu May 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Mar 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Mohammad Iqbal Hossain Email Addresses
FAQ About Mohammad Iqbal Hossain
-
Mohammad Iqbal Hossain is located at
Nashville, Tennessee, United States -
Mohammad Iqbal Hossain is a
Dedicated and accomplished professional with 20 years of hands on experience in pharmaceutical Industry including Analytical and Formulation R&D in Liquid formulation development for ANDA submission. Extensive set of skills combined with both the formulation and Analytical R&D aspects. Specialties:Experienced in the following areas of operations: • Pre-Formulation and Formulation development for ANDA submission, Lipid based Nano suspension (LNP's). • Pharmaceutical Development Report ( PDR) , Quality by design, Risk assessment, Excipient Compatibility Studies, DOE batches, Relevant module for FDA filing , Deficiency handling, CRL responding • UPLC-H class, HPLC, GC, PSD, TOC, PDA, RI, ELSD,CAD, Zetasizer, and all other laboratory equipment • Routine QC analysis of pharma API, Excipients, Process Intermediates & formulated drug products • Waters Empower 3, Agilent chemstation, Agilent EZ chrom, Shimadzu class Vp, Shimadzu prominence, dionex & chromeleon integrated software. • Laboratory deviation & OOS investigation. • Analytical Method Development (HPLC) • Phase appropriate Analytical Method Validation for clinical studies • Analytical method validation protocol & report • Product Stability testing • Preparation of stability protocol & stability report • Laboratory equipment Calibration & Qualification including environmental chambers for stability testing. • Laboratory document preparation • Process validation/ holding time validation/ transport validation/ Freeze-thaw analysis • Cleaning validation • CAPA and Change Control handling • Extractable & Leachable (E&L) testing, RLD reverse engineering • Analytical tech transfer • Weak Product Assessment based on the frequency of OOS, OOT and the number of planned/unplanned changes over the product life cycle and remedial actions. August Bioservices -
Mohammad Iqbal Hossain currently works in the
August Bioservices -
Mohammad Iqbal Hossain specializes in
Dedicated and accomplished professional with 20 years of hands on experience in pharmaceutical Industry including Analytical and Formulation R&D in Liquid formulation development for ANDA submission. Extensive set of skills combined with both the formulation and Analytical R&D aspects. Specialties:Experienced in the following areas of operations: • Pre-Formulation and Formulation development for ANDA submission, Lipid based Nano suspension (LNP's). • Pharmaceutical Development Report ( PDR) , Quality by design, Risk assessment, Excipient Compatibility Studies, DOE batches, Relevant module for FDA filing , Deficiency handling, CRL responding • UPLC-H class, HPLC, GC, PSD, TOC, PDA, RI, ELSD,CAD, Zetasizer, and all other laboratory equipment • Routine QC analysis of pharma API, Excipients, Process Intermediates & formulated drug products • Waters Empower 3, Agilent chemstation, Agilent EZ chrom, Shimadzu class Vp, Shimadzu prominence, dionex & chromeleon integrated software. • Laboratory deviation & OOS investigation. • Analytical Method Development (HPLC) • Phase appropriate Analytical Method Validation for clinical studies • Analytical method validation protocol & report • Product Stability testing • Preparation of stability protocol & stability report • Laboratory equipment Calibration & Qualification including environmental chambers for stability testing. • Laboratory document preparation • Process validation/ holding time validation/ transport validation/ Freeze-thaw analysis • Cleaning validation • CAPA and Change Control handling • Extractable & Leachable (E&L) testing, RLD reverse engineering • Analytical tech transfer • Weak Product Assessment based on the frequency of OOS, OOT and the number of planned/unplanned changes over the product life cycle and remedial actions. -
Mohammad Iqbal Hossain speaks the following languages:
No languages available. -
Mohammad Iqbal Hossain has prior experience in the following industries:
Lannett , Lannett , Novartis , Novartis , Novartis , Novartis -
Mohammad Iqbal Hossain has the following professional experience:
August Bioservices , Lannett , Lannett , Novartis , Novartis , Novartis , Novartis . -
You can view Mohammad Iqbal Hossain’s
LinkedIn profile at LinkedIn URL. -
Mohammad Iqbal Hossain’s work email addresses are
[email protected] . -
Mohammad Iqbal Hossain works at
August Bioservices
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