Experience

Agios Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• DMPK

  • Jan 2022 - Present

  Cambridge, Massachusetts, United States



Sumitomo Pharma Oncology

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Associate Director, CPDM

  • Mar 2019 - Jan 2022

  Cambridge, Massachusetts, United States



Boston Biomedical, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Scientist, Clinical Pharmacology

  • Feb 2018 - Mar 2019

  Cambridge, MA Non-clinical ADME: Leading non-clinical ADME efforts in support of regulatory filing gap analysis. Clinical Pharmacology: Leading clinical pharmacology studies (DDI, AME) in support of small molecules programs for NDA filing. Clinical DMPK: Leading FIH metabolite profiling and pharmacokinetic activities in support of small molecules programs

• Scientist I/Associate Manager

  • May 2015 - Feb 2018

  Cambridge, MA Formulation/Drug Product development • Developed lipid and polymer nanoparticle based parental formulations for RNAi therapeutics • Lead formulation scaling up and manufacture activities in support of IND enabling PK/TK studies, CMC Clinical Bioanalytical /Pharmacokinetics • Oversaw GLP Clinical Bioanalysis activities at CRO • Performed Clinical PK Analysis (Phoenix WinNonlin NCA, BioEquivalance) Project/CRO Management • Oversaw and managed clinical PK operational… Show more Formulation/Drug Product development • Developed lipid and polymer nanoparticle based parental formulations for RNAi therapeutics • Lead formulation scaling up and manufacture activities in support of IND enabling PK/TK studies, CMC Clinical Bioanalytical /Pharmacokinetics • Oversaw GLP Clinical Bioanalysis activities at CRO • Performed Clinical PK Analysis (Phoenix WinNonlin NCA, BioEquivalance) Project/CRO Management • Oversaw and managed clinical PK operational activities, contracts and bioanalysis activities at CRO (method transfer, GLP MD/MV), negotiated 20% reduction in analysis cost • Lead the reviewing efforts of Phoenix WinNonlin NCA workspace and drafts for NCA study reports • Participated NDA-enabling preclinical and clinical pharmacology gap analysis, including non-clinical ADME for parent and metabolite, QWBA in pigmented rats, Clinical DDI study • Participated population PK data cleaning and dataset assembly • Performed weekly experimental planning and monthly progress reviews with direct reports, provided quarterly summary reports to supervisor

• Postdoctoral Research Scientist

  • Sep 2012 - May 2015

  Cambridge, MA RNAi Synthesis • Improved in-house automated oligonucleotide synthesis efficiency from medium throughput to high throughput Formulation/Drug Product development • Developed solid, semi-solid oral dose forms and nanoparticle based parental formulations for small molecule and RNAi therapeutics • Performed formulation optimization and developed characterization assays (Dissolution, DSC, Karl-Fisher, HPLC, Particle Size Analysis), determined specifications for scaling… Show more RNAi Synthesis • Improved in-house automated oligonucleotide synthesis efficiency from medium throughput to high throughput Formulation/Drug Product development • Developed solid, semi-solid oral dose forms and nanoparticle based parental formulations for small molecule and RNAi therapeutics • Performed formulation optimization and developed characterization assays (Dissolution, DSC, Karl-Fisher, HPLC, Particle Size Analysis), determined specifications for scaling up Bioanalytical Method Development/Clinical PK • Developed small molecule and oligo nucleotide therapeutics bioanalysis assays over various platforms (LC/MS, Hybridization ELISA) • Optimized plasma and tissue extraction protocols, improved recovery to >90% • Participated GLP Bioanalysis method transfer to CRO • Performed Clinical Bioanalysis and clinical PK (Phoenix WinNonlin NCA) Project Management of PK related clinical operation activities and clinical bioanalysis



Tufts University

• United States
• Higher Education
• 700 & Above Employee

• Post-doc

  • Oct 2010 - Sep 2012

  Medford, MA Establishing lab space and initiate projects; Leading a group of grad and undergrad students on various research projects; Synthesizing new lipid-like materials for DNA and siRNA delivery; 3D and patterned cell culture; Protein and virus drug formulation; Nature inspired micro and nano-fabrication for tissue engineering.



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Co-op

  • Jan 2009 - Oct 2010

  Organic synthesis and hydrophobic modification of PEG based macromers; Formulations of various in-situ polymerization systems of hydrogels for adhesion prevention and as tissue sealant; Fundamental analysis of the effects of macromer hydrophobicity and comonomer on the in-situ polymerization efficiency of various initiation systems; Protein drug delivery.



Worcester Polytechnic Institute

• United States
• Higher Education
• 700 & Above Employee

• Teaching Assistant

  • Oct 2004 - May 2010

  Intro. to Materials Science, Biomaterials, Materials Processing, Plastics.



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Student Intern

  • Oct 2007 - Jul 2008

  Framingham, MA Organic synthesis of macro-monomer; formulation and characterization of Biodegradable hydrogels.