Director

• Mar 2023 - Present

Principal Scientist

• 2021 - Present

As a Principal Scientist I am responsible for overseeing early and late-stage drug development projects including formulation development, structural/biophysical characterization and analytical method development. Some key functions include: - Development of liquid formulation for IV and intranasal administration - Development of early stage analytical methods to enable clinical use of IgM antibodies - Characterization of IgM antibody structure, binding and function - Recent IND… Show more As a Principal Scientist I am responsible for overseeing early and late-stage drug development projects including formulation development, structural/biophysical characterization and analytical method development. Some key functions include: - Development of liquid formulation for IV and intranasal administration - Development of early stage analytical methods to enable clinical use of IgM antibodies - Characterization of IgM antibody structure, binding and function - Recent IND approval for IGM-6268 (intranasally administered IGM-6268, an anti-SARS-CoV-2 IgM monoclonal antibody)

Senior Scientist

• Mar 2019 - Mar 2021

IgM antibody formulation, analytics, characterization and tech transfer to support accelerated IND submissions - Supported IND submission for IGM-2323, a potential treatment of relapsed/refractory (r/r) B-cell non-Hodgkin lymphoma (NHL) in 2019 - CMC lead IGM-8444, an antibody targeting Death Receptor 5 (DR5) for the treatment of patients with solid and hematologic malignancies (IND approved in 2020)

Scientist II

• Jun 2016 - Mar 2019

Protein characterization and development scientist involved with BLA (AndexXa®) and MAA (IndexXa®) approvals during a dynamic clinical to commercial company phase transition - Led protein characterization projects to fill information gaps in breakthrough designation drug program - Developed and managed the validation of critical biochemical methods at various CROs including methods to establish identity and quantitate purity, product related… Show more Protein characterization and development scientist involved with BLA (AndexXa®) and MAA (IndexXa®) approvals during a dynamic clinical to commercial company phase transition - Led protein characterization projects to fill information gaps in breakthrough designation drug program - Developed and managed the validation of critical biochemical methods at various CROs including methods to establish identity and quantitate purity, product related variants, and impurities - Characterized degradation pathway and demonstrated overall protein analytics strategy was stability indicating - Successfully trained personnel and transferred technology (GMP methods) between CROs in USA and Europe - Skilled with data analysis using statistical software for trending, outlier identification and product specification - Contributed to the CMC sections of FDA and EU submissions (BLA, MAA, RFIs) Show less Protein characterization and development scientist involved with BLA (AndexXa®) and MAA (IndexXa®) approvals during a dynamic clinical to commercial company phase transition - Led protein characterization projects to fill information gaps in breakthrough designation drug program - Developed and managed the validation of critical biochemical methods at various CROs including methods to establish identity and quantitate purity, product related… Show more Protein characterization and development scientist involved with BLA (AndexXa®) and MAA (IndexXa®) approvals during a dynamic clinical to commercial company phase transition - Led protein characterization projects to fill information gaps in breakthrough designation drug program - Developed and managed the validation of critical biochemical methods at various CROs including methods to establish identity and quantitate purity, product related variants, and impurities - Characterized degradation pathway and demonstrated overall protein analytics strategy was stability indicating - Successfully trained personnel and transferred technology (GMP methods) between CROs in USA and Europe - Skilled with data analysis using statistical software for trending, outlier identification and product specification - Contributed to the CMC sections of FDA and EU submissions (BLA, MAA, RFIs) Show less

Scientist I

• 2015 - 2016

Postdoctoral Fellow

• Dec 2013 - Jun 2015

Elucidated the biochemical mechanism of the cobalamin-independent Methionine Synthase protein (Met6p), which is a key enzyme in fungal metabolism and a drug design target for Nosocomial Candidiasis, using structure/function studies (2015 publication) - Crystallized and solved the first substrate induced closed conformation resembling the likely transition state - Characterized the role of key amino acids in the active site by site directed mutagenesis and enzyme… Show more Elucidated the biochemical mechanism of the cobalamin-independent Methionine Synthase protein (Met6p), which is a key enzyme in fungal metabolism and a drug design target for Nosocomial Candidiasis, using structure/function studies (2015 publication) - Crystallized and solved the first substrate induced closed conformation resembling the likely transition state - Characterized the role of key amino acids in the active site by site directed mutagenesis and enzyme activity - Proposed the structural reorganization required for transition from the resting ‘open’ conformation to transient ‘closed’ conformation by systematically studying many substrate bound structures which showed substrate and metal ion induced structural rearrangements required for catalysis - Used Met6p protein structure expertise, virtual ligand docking programs and X-ray Crystallography to identify the compound, S-Adenosyl-L-Homocysteine, as drug scaffold for future anti-Met6p SAR studies

Graduate Student

• Aug 2008 - Dec 2013

Completed cross-disciplinary coursework (Molecular Biology, Cell Biology, Genetics, Biochemistry, Enzyme Kinetics) Tested the thesis that an inhibitor against an essential and structurally unique fungal enzyme called methionine synthase (Met6p) should selectively kill pathogenic fungi in blood stream infections with no harm to the host - Crystallized and solved the structure of the Met6p enzyme using protein engineering - Used a comprehensive drug discovery strategy to… Show more Completed cross-disciplinary coursework (Molecular Biology, Cell Biology, Genetics, Biochemistry, Enzyme Kinetics) Tested the thesis that an inhibitor against an essential and structurally unique fungal enzyme called methionine synthase (Met6p) should selectively kill pathogenic fungi in blood stream infections with no harm to the host - Crystallized and solved the structure of the Met6p enzyme using protein engineering - Used a comprehensive drug discovery strategy to identify small molecule inhibitors against the Met6p target, including the development and use of high-throughput biophysical and kinetic screening assays, protein crystallization, and structure based drug design/screening - Characterized the Met6p active site using ligand bound structures and site-directed mutagenesis - Published 2 research papers - Trained, mentored and managed undergraduate researchers and lab technicians - Attended and presented research at national scientific conferences

Associate I in QC Analytical Technology

• Oct 2006 - Aug 2008

Developed, optimized and validated a variety of analytical methods to support Novartis’ biopharmaceutical projects Developed, optimized and validated a variety of analytical methods to support Novartis’ biopharmaceutical projects

Summer Intern

• Jun 2006 - Sep 2006

Investigated the secretion pathway of a highly expressed protein from Aspergillus oryzae relevant for biofuel research Investigated the secretion pathway of a highly expressed protein from Aspergillus oryzae relevant for biofuel research

Undergraduate Researcher

• Jun 2004 - Aug 2006

Investigated the presence and activity of the DNA repair proteins FPG and OGG in the chloroplast Investigated the presence and activity of the DNA repair proteins FPG and OGG in the chloroplast

Summer Intern

• Jun 2005 - Sep 2005

Developed a restriction map assay Developed a restriction map assay