Experience

Constellation Pharmaceuticals, A MorphoSys Company

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Manager Analytical Development CMC

  • Mar 2021 - Present

  Cambridge, Massachusetts, United States



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist

  • Aug 2018 - Mar 2021

  Greater San Diego Area Oversee phase appropriate method development and method transfer for small molecule API, peptide, spray dried intermediates and drug products using HPLC, UPLC, GC, USP dissolution apparatus as well as compound specific cleaning validation. Responsible for overall project execution by developing strategic experimental plans & timelines and lead analytical CMC discussions with clients. Review/Author drug product analytical sections of INDs, IMPDs and regulatory filing documents for… Show more Oversee phase appropriate method development and method transfer for small molecule API, peptide, spray dried intermediates and drug products using HPLC, UPLC, GC, USP dissolution apparatus as well as compound specific cleaning validation. Responsible for overall project execution by developing strategic experimental plans & timelines and lead analytical CMC discussions with clients. Review/Author drug product analytical sections of INDs, IMPDs and regulatory filing documents for customers. Manage outsourced activities from vendors to internal Catalent labs to support DP testing. Author and review product specifications, protocols, validation reports, OOS/OOT investigations and deviations. Evaluating physiochemical properties of the molecule and determine the best fit-for‐purpose solubilization technology Support formulation and engineering teams with solvent selection, polymer selection, spray dried dispersion and oral solid dosage form development. Perform business development related activities for pharmaceutical clients through participation in technical discussions, drafting/review of proposals, and development of collaborative/scientific relationships across global Catalent sites. Work with leads in overseeing hiring, staffing, training and organization of team and managing group budget. Lead a group of 3-4 chemists and their projects, work with clients as primary point of communication from kick-off to method validation. Collaborate with manufacturing and quality teams on analytical method validation and compliance issues. Show less



Liquidia Corporation

• United States
• Biotechnology Research
• 1 - 100 Employee

• Scientist

  • Jan 2016 - Aug 2018

  Primary role for 6 years: Analytical method development and phase appropriate qualification Early phase IND enabling data generation and management Ph-III readiness QC systems and lab setup for commercial readiness

• Senior Associate Scientist

  • Jul 2013 - Dec 2015

  Morrisville

• Associate Scientist

  • Oct 2012 - Jun 2013

  Morrisville



Campbell University

• United States
• Higher Education
• 700 & Above Employee

• Formulations and Quality Control (QC) Associate

  • Aug 2012 - Sep 2012

  Buies Creek Performed routine QC testing for tablet and capsules for dissolution, disintegration, content uniformity and weight variation as per USP monographs. Perform stability testing for solid dosage forms as per the SOPs. Performed routine raw material (API and excipients) testing using HPLC for assay/purity, water content by Karl Fischer titrimetry, FTIR, DSC and TGA. Performed pre-formulation studies for tablet formulations along with flow property testing (angle of repose) using Flodex.… Show more Performed routine QC testing for tablet and capsules for dissolution, disintegration, content uniformity and weight variation as per USP monographs. Perform stability testing for solid dosage forms as per the SOPs. Performed routine raw material (API and excipients) testing using HPLC for assay/purity, water content by Karl Fischer titrimetry, FTIR, DSC and TGA. Performed pre-formulation studies for tablet formulations along with flow property testing (angle of repose) using Flodex. Drafted and reviewed batch records and SOPs, performed and documented major and minor cleaning validation of equipment in GMP areas and assisted in maintaining chemical inventory records. Show less



Campbell University

• United States
• Higher Education
• 700 & Above Employee

• Laboratory Assistant

  • Aug 2011 - May 2012

  Buies Creek As a part of graduate research performed systematic physical-chemical characterization of a phospholipid using FTIR, DSC, TGA, PXRD, Karl Fischer, Hot stage polarization microscopy and developed a Chloroform free reverse phase HPLC method to analyze the chemical stability of the heated phospholipid



PERC, Campbell University

• Teaching Assistant/ Lab Assistant

  • Aug 2011 - May 2012

  Buies Creek Trained students in operating instruments like HPLC, GC, UV-Vis, Malvern Zetasizer Nano, USP dissolution and disintegration apparatus, FTIR, TOC, Karl Fischer, DSC, TGA and lyophilizer. Trained students in a GMP qualified environment in the manufacture of tablets using multi-station tablet press, capsule filling, powder blending and semi-solid dosage forms.



Campbell University

• United States
• Higher Education
• 700 & Above Employee

• Graduate Assistant

  • Aug 2010 - May 2011

  Buies Creek Maintained chemical inventory records, performed literature search on ADME profiles, assisted in laboratory set up and helped my professor in reviewing the text book he was writing.