Analytical Chemistry Drug Development

Summary:

Analytical Chemistry, separation sciences, mass spectrometry and regulatory scientist specializing in drug development and regulatory submissions from pre-clinical to commercialization of small molecules, oligonucleotides and antibody drug conjugates (ADCs). Proven leadership in guiding drug development projects and managing scientific teams. Mentored/trained and developed scientific staff emphasizing on planning and managing short-term and long-term development activities. Adept at cross-functional collaboration with regulatory affairs, formulation development, and clinical development teams. Renowned for an innovative approach with a track record of developing novel analytical chiral and achiral HPLC/SFC/MS/MS methods. International experience provides a global perspective, enabling seamless work in diverse cultural settings. Industry-specific expertise includes developing stability-indicating analytical methods for small molecules, peptides, and oligonucleotides. Extensive knowledge in API development, pre-formulation, and pharmaceutical development. Successfully coordinated with internal and external stakeholders for method scale-up, transfer, and implementation.

In addition to the above unique expertise, I have a strong background in method development, validation and characterization of APIs using a range of analytical techniques, including HPLC, SFC, UHPLC, SFC/LC/MS, LC-MS/MS, UV/VIS, DAD, ELSD, GC-FID, HS-GC, SEC, KF, TGA and Atomic Absorption spectroscopy. I also have a strong interpretation background in organic structures from combined spectra (UV, IR, NMR, MS) and excellent GMP documentation and project management skills. I have also instructed various Analytical Chemistry courses and practicum classes in university settings.

Professional Experience:

Eurofins — Principal Scientist, CMC (May 2023 – Present):

Led preparation, technical, and regulatory review of CMC sections for global CTA submissions for multiple projects: small molecules and antibody-drug conjugates (ADCs).

Proactively reviewed molecule-specific CMC development strategies and submission content.

Made technical decisions on global CMC regulatory issues impacting product submissions.

Led key regulatory CMC activities, planning, writing, and reviewing documents for IND and NDA/amendment submissions.

Implemented technical solutions and analytical strategies for successful regulatory submissions.

Utilized country-specific Response to Questions (RtQ) approaches leading to successful approvals. Regulatory Content Management: Veeva Vault - QualityDocs, RIM, and Clinical.

Charles River Laboratories — Research Scientist II (Principal Investigator) (Oct 2018 – Jan 2023):

Designed and executed scientific testing strategies and studies. Served as Principal Investigator, leading assay development, validation, and study conduct including resource allocation and project management beyond completion.

Authored CMC sections of analytical chemistry method reports and safety assessment reports.

Led client projects (over 150/year) to completion, including synthetic small molecules, peptides, and oligonucleotides.

Independently functioned as a Study Director/Principal Investigator for GLP projects and supported cross-functional Analytical Chemistry and Formulation development.

Implemented SOPs and evaluated project performance using Chromeleon™ and TrackWise.

Olon Ricerca Biosciences — Scientist, Analytical Chemistry (Jan 2016 - Sep 2018):

Authored CMC sections for analytical chemistry validation reports, stability studies, and release test reports.

Led GLP/GMP (over 50/year) characterization studies as a Study Director/Principal investigator, including protocol development and data verification.

Developed and validated HPLC procedures for small molecules in a GMP environment.

Coordinated compliant data generation for client projects, managing OOS/deviations/investigations.

Authored protocols and reports, ensuring regulatory compliance for technology transfer.

Implemented IQ/OQ/PQ for HPLC and UHPLC instrumentation, managed data using LIMS.

GlaxoSmithKline (on behalf of A10 Clinical solutions) (2014 - 2015):

Developed HPLC methods for API process chemistry development and intermediates in a synthetic route.

Validated HPLC/GC drug product assay and impurity methods in a cGMP environment.

Conducted stability testing, chiral, achiral analysis using Empower 3, and electronic notebook.

Ghent University, Pfizer Analytical Research Center, Belgium (2009 - 2014):

Ph.D. in Analytical Chemistry, specializing in LC/SFC methods development and column chemistry evaluations. Managed HPLC/SFC systems maintenance and troubleshooting.

Critically re-evaluated SFC for analysis of achiral and chiral pharmaceuticals. Demonstrated a modular LC upgrade to SFC instrumental setup for robust data.

Education: Ph.D. in Analytical Chemistry, Ghent University, Department of Chemistry, Separation Science Group/Pfizer Analytical Research Center, Belgium, 2014.

Dissertation: “Supercritical Fluid Chromatography and Enhanced Fluidity Liquid Chromatography: Green alternatives to conventional LIQUID CHROMATOGRAPHY”

Transferable Skills:

Information management, time management, organization, customer service, project management, strategic planning, professional awareness, adaptability.

Volunteer Services: Scientific Reviewer: Elsevier/TALANTA (Talanta Journal ScienceDirect.com by Elsevier) and Garden Associate: Growing Places Indy (https://www.growingplacesindy.org/).

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