Summary

Proven success in the development of innovative analytical support and solutions. Analytical Chemistry, Separation Sciences and Mass Spectrometry - Expertise in Analytical drug development - early stage pre-clinical, Phase I - III.

Dedicated, enthusiastic and results-driven quality professional with strong background and experience in method development and validation using HPLC, SFC, UHPLC, SFC/LC/MS, LC-MS/MS, UV/VIS, DAD, ELSD, GC-FID; HS-GC and Atomic Absorption spectroscopy for pharmaceuticals, natural products, environmental and food samples.

Maintained and provided notebooks, records, reports, action/check lists and documentation which are current, legible, readily understood, complete and accurate to ensure compliance with established procedures and specifications, and are verifiable as required or requested.

Reviewed fellow Scientist's work, including complex records of experimentation, to ensure completeness and accuracy.

Purification in SFC and LC with mass directed fraction collection.

Strong interpretation background in organic structures from combined spectra (UV, IR, NMR, MS).

Excellent project management skills and ability to manage multiple tasks for successful completion.

Coordinates and partners with internal and external customers for scale-up, transfer and implementation of new methods and technologies within area of expertise.

Up to 8 awards, 8+ years of experience in research/teaching, analysis, reporting, publications and teamwork.

Professional Experience

Charles River Laboratories Oct 2018 – Jan 2023

Research Scientist II (Principal Investigator)

Scientific & Laboratory Management -Designed and/or executed scientific testing strategies and studies. Leads assay development, assay validation or study conduct etc. Reviewed and interpreted study data, communicated results to clients and wrote final reports. Served as Principal Investigator, Project Leader or Study Director, as applicable. Ensured compliance with protocols and all applicable SOPs. Troubleshot and resolved assay or technical issues in the laboratory when scientific expertise is needed. Provided advisory functions to clients designing a program or experiment, dealing with specific dataset interpretation, or when appropriate answering questions from regulatory authorities.

Lead several client projects (over 100/year) to successful completion including siRNA, Oligonucleotides

Functioned independently as a Study Director/Principal Investigator in research studies of moderate to high complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects.

Supported cross-functional Analytical Chemistry and Formulation development.

Created SOPs and provided appropriate training

Reviewed raw data and analytical reports; and perform data integrity checks

Data management: Chromeleon™ Chromatography Data System (CDS); TrackWise QMS Software

Olon Ricerca Biosciences, Concord, OH, USA Jan 2016 - Sep 2018

Scientist, Analytical Chemistry

Study Director of GLP Projects

oStudy Director for GLP characterization studies.

o Developed protocols

o Reviewed and ensured experimental data are recorded and verified and documented

oIssued Certificate of Analysis and reports covering (HPLC, IR, NMR, TGA, KF, GC...)

Developed & validated HPLC procedures for small molecule drug substances & drug products

Performed forced degradation studies & developed stability indicating assay & impurities

In GMP laboratory, coordinated timely & compliant generation of data to support client projects

Managed OOS/deviations/investigations and change control activities related to the analytical documentation and testing

Authored protocols and reports; reviewed data for technical content and regulatory compliance

Maintained current expertise with relevant ICH, GMP, and FDA guidelines

Implemented HPLC and UHPLC instrumentation IQ/OQ/PQ

Data management: LIMS

GlaxoSmithKline, King of Prussia, PA, USA 2014 - 2015

Scientist (Contract position on behalf of A10 Clinical solutions)

Responsibilities

Developed HPLC methods for starting materials and intermediates in synthetic route of early to late phase active pharmaceutical ingredient (API) process chemistry development

Developed and validated HPLC/GC drug product assay and impurity methods in a cGMP environment according to ICH guidelines

Stability testing, chiral and achiral analysis

Chloride content using titrators

Information systems: Empower 3, electronic notebook and LIMS

Ghent University, Pfizer Analytical Research Center, Belgium 2009 - 2014

PhD student

Responsibilities

Responsible for LC/SFC methods development and validation for active pharmaceutical ingredient (API)

Stationary phase evaluation, robustness tests and method transfers

HPLC/SFC system performance evaluation and system comparisons; fundamental studies on separation sciences and mass spectrometry with emphasis on SFC

Proven ability to manage HPLC/SFC systems maintenance and troubleshooting

Accomplishments

Critically re-evaluated SFC for analysis of achiral and chiral pharmaceuticals

Demonstrated simple modular LC upgrade to SFC instrumental setup can be built to provide data with equally robust as HPLC

Education

Ph.D. Chemistry (Analytical), Ghent University, Department of Organic 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 and organization.

Customer service skills.

Project management and strategic planning.

Professional awareness and adaptability.

Contribution for scientific community: Scientific Reviewer Elsevier/TALANTA

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