プロフィール詳細

プロジェクトを作成

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Dr. Sardar Mohammed J.に依頼

United States

Senior CMC & Analytical Chemistry Expert | HPLC/LC-MS, Impurities, Stability | PhD Peptide Chemist & Patent Holder

プロフィール概要

I am a PhD-trained Analytical & Peptide Chemist with 20+ years of experience supporting global pharmaceutical, herbal, cosmetic, nutraceutical, and food/beverage companies. My work spans analytical development, impurity control, formulation strategy, stability science, and regulatory CMC documentation for injectable, peptide, oral solid, topical, and natural product systems. Founder: 🌐 UMFIS™ & UMFIS-F™ (Patent Pending)— My Proprietary Scientific Intelligence Systems (UMFIS™ & UMFIS-F are the world’s first universal computational engine capable of evaluating ANY molecules and ANY formulation— including small molecules, complex molecules, peptides, biologics, herbal extracts, and multi-component natural matrices & Foods. Inventor of: UMFIS™ (Pharmaceuticals) Universal Molecular Formulation Intelligence System → Molecule scoring, impurity risk, excipient mapping, formulation blueprinting. UMFIS-F™ (Food, Nutraceuticals & Beverages) Ingredient scoring, stability prediction, sensory impact mapping, shelf-life modeling. These systems provide standardized, rapid, industry-ready insights. 🔬 Analytical Expertise (20+ Years) Proficient in advanced analytical platforms for both R&D and QC: HPLC, UPLC, LC-MS/MS, GC-MS, IC, FTIR, UV-Vis Stability-indicating method development (ICH Q2/Q14) Dissolution (immediate + modified release) Excipient compatibility + forced degradation Nitrosamine & genotoxic impurity risk assessment Method validation, transfer, troubleshooting CRO/CDMO oversight (methods + CMC submissions) I provide rapid identification, mechanistic interpretation, and mitigation strategies for impurities, degradation pathways, and formulation–analytical relationships. 📘 Patent-Focused Scientific Innovator I have authored peer-reviewed publications and multiple patents, including: Dalbavancin Injectable Stability Patent (peptide stabilization & degradation control) Herbal Topical Formulation Patent (balm/cream/ointment CO₂ extract systems) Provisional Patent for Multi-Component Oral Dosage System Utility Patent in Preparation These demonstrate an ability to create novel, IP-protectable formulation strategies across pharmaceuticals and natural products. 🌿 Herbal, Cosmetic & Natural Product Formulation Founder of Greenoura Health, where I develop: Natural balms, botanical emulsions, serums, CO₂-extract systems Clean-label skincare + haircare formulations Herbal/CO₂ extract stability optimization Antioxidant + anti-degradation strategies Sensory improvement, pH/aw tuning Shelf-life prediction and preservative validation I specialize in turning complex natural materials into stable, manufacturable consumer products. 🥤 Food, Nutraceutical & Beverage Chemistry Using my analytical and stability background, I support: Functional food and supplement formulation RTD beverage evaluation (flavor, stability, pH, shelf-life) Protein stability, oxidation, aggregation Natural ingredient chemistry + interaction pathways Taste/texture analysis through analytical interpretation Clean-label preservative + ingredient strategy I bridge food science with pharmaceutical-level analytical rigor. 📑 CMC, Regulatory & Scientific Writing (Fast Turnaround) I have authored, reviewed, and defended: ANDA/NDA CMC analytical sections Validation protocols and summary reports Impurity justification and toxicology rationale Stability summary reports (ICH) FDA/EMA/Health Canada deficiency responses Technical memos, risk assessments, and comparability reports I also apply AI-assisted scientific drafting to deliver documents faster, with higher technical clarity. 📌 Available Immediately For: Pharma & Analytical • Analytical method development • Impurity & degradation mechanism analysis • Nitrosamine assessment • Stability studies (design + interpretation) • CMC sections (ANDA/NDA/DMF/PAS) • Technical reports, protocols, responses Formulation • Peptide + small molecule formulation • Herbal, cosmetic, natural product formulation • Ingredient compatibility • Degradation mitigation • Shelf-life extension Food & Beverage • RTD beverage evaluation • Nutraceutical formulation review • Clean-label ingredient optimization IP/Innovation • Patent-ready formulation strategy • Scientific drafting for patents • UMFIS™/UMFIS-F™ computational scoring

専門分野

• ★ Analytical Chemistry
• ★ Drug Development
• ★ CMC Documentation
• ☆ Deformulation
• ☆ Separation & Purification
• ☆ Crystallography
• ☆ X-Ray Crystallography
• ☆ Spectrophotometry
• ☆ Mass Spectrometry
• ☆ Liquid Chromatography/HPLC
• ☆ Thermal Analysis
• ☆ Gas Chromatography
• ☆ Particle Size Distribution
• ☆ Optical Rotation
• ☆ Food Chemistry
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Regulatory Writing
• ☆ Formulation
• ☆ Nutraceuticals

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Business & Legal Writing

Research Gap Analysis, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Stability/Shelf Life Testing, Quality Assurance & Control (QA/QC), Reverse Engineering

職務経験

Sr. Scientist

Regulated Pharmaceutical Company

7月 2015 - 現在

学歴

PhD (Chemistry )

Northeastern University

9月 2018 - 12月 2022

Master of Science (MS) (Pharmaceutical Chemistry)

University of Kansas

7月 2015 - 7月 2017

Master of Science (MS) (Chemistry)

Aligarh Muslim University

5月 1995 - 5月 1997

Bachelor of Science (Chemistry)

Aligarh Muslim University

3月 1992 - 5月 1995

認定資格

• GMP / ICH Compliance Training

  Internal/Online Training

  1月 2025 - 現在

• Basics of eCTD Submission

  Pharma Lesson Masterclass

  1月 2025 - 現在

• Pharmaceutical Pre-formulation: Basics and Industrial Applications

  Lab-Training.com

  1月 2025 - 現在

出版物

PATENT

Jakaria, S. (2025). UMFIS-F™ — Universal Molecular Formulation Intelligence System for Food (ZPI-NF™) (Provisional Patent). Independent invention. Nutraceutical and food performance intelligence system integrating multi-domain scoring for functional products.

Jakaria, S. (2025). UMFIS™ — Universal Molecular Formulation Intelligence System (Provisional Patent). Independent invention. Pending patent application integrating multi-module ZPI-D™ scoring for molecular discovery intelligence.

Sardar Mohammed Jakaria, James Murtagh, James Murtagh, Gurmukh Channa (2022). STABLE, READY-TO-ADMINISTER AQUEOUS FORMULATIONS OF DALBAVANCIN . PCT International Patent Application, Serial No. PCT/US2022/051653.

JOURNAL ARTICLE

n/a .

Sardar M. Jakaria, David E. Budil, James Murtagh (2023). Strategies to Stabilize Dalbavancin in Aqueous Solutions; Section-1: the Effects of Metal Ions and Buffers . Pharmaceutical Research.

Sardar M. Jakaria, David E. Budil, James Murtagh (2023). Strategies To Stabilize Dalbavancin in Aqueous Solutions; Section 3: The Effects of 2 Hydroxypropyl-β-Cyclodextrin and Phosphate Buffer with and without Divalent Metal Ions . Pharmaceutical Research.

Sardar M. Jakaria, David E. Budil, James Murtagh (2023). A Systematic Degradation Kinetics Study of Dalbavancin Hydrochloride Injection Solutions . Journal of Pharmaceutical Sciences.

Sardar M. Jakaria, David E. Budil, James Murtagh (2023). Strategies to stabilize dalbavancin in aqueous solutions: Section 4—identification of heat degradation products in 2-hydroxypropyl-β-cyclodextrin and divalent metal ion solutions at pH 4.5 and 7.0 . AAPS Open.

Sardar M. Jakaria, David E. Budil, James Murtagh (2022). Glycopeptide antibiotic drug stability in aqueous solution . AAPS Open.

DISSERTATION THESIS

Sardar Mohammed Jakaria (2022). A Systematic Study of Stabilizing Lipoglycopeptide (Dalbavancin) Therapeutic Drugs in Aqueous Solution . ProQuest.

Sardar Mohammed Jakaria (2017). A Systematic Degradation Kinetics Study of Gemcitabine Hydrochloride Injection Solution . ProQuest.

Sardar Mohammed Jakaria (1997). Studies on Ion Conduction in CuI-Ag2WO4 Systems. Aligarh Muslim University, Aligarh, India.