Mohammad Iqbal Hossain

About Mohammad Iqbal Hossain

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 IND, NDA, 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, FL, CD, QDa-Mass, QToF, FID, Zetasizer, and all other laboratory equipment • Method Development of pharma API, Excipients, Process Intermediates & formulated drug products, Peptide, Polypeptide and all traditional small molecules• Waters Empower 3, Agilent chemstation, Agilent EZ chrom, Shimadzu class Vp, Shimadzu prominence, dionex & chromeleon integrated software. • Laboratory deviation & OOS investigation.• Analytical Method Development from Scratch• Phase appropriate Analytical Method Validation for clinical studies • Analytical method validation protocol & report• Analytical method development/ validation at trace level for Cleaning Validation• 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.

Experience

1. Principal Scientist, Analytical Development

   August Bioservices, LLC

   Apr 2022 — Present · Nashville, TN, US

   Experienced Principal Scientist with expertise in analytical method development for small molecules, including phase-appropriate method development and validation. Skilled in authoring comprehensive protocols and reports, troubleshooting technical challenges, and collaborating with scientific groups to address complex inquiries. Adept at delivering innovative, high-quality solutions to meet regulatory and client requirements.

Education

• University of Chittagong

  BS, Chemistry

  1992 — 1996

• University of Chittagong

  MS, Chemistry

  1997 — 1999

• Bangladesh Open University

  Master of Business Administration - MBA, Marketing/Marketing Management, General

  2008 — 2011

Skills

• Hplc Method Development
• Good Laboratory Practice (Glp)
• Hplc Method Validation
• Regulatory Affairs
• Glp
• Gmp
• Standard Operating Procedure (Sop)
• Process Validation
• Analytical Tech Transfer
• Project Management
• Stability Testing
• Regulatory Submissions