Boston, Massachusetts, United States
An innovative analytical leader with expertise in the development of cell therapy and other novel modalities. Driven to lead successful, cross-functional, dynamic teams to deliver new treatments for patients. Experienced in matrix and direct leadership, analytical development, pre-clinical and clinical drug development, regulatory filings and guidelines. Excellent communication, leadership and mentorship skills. Technically skilled in molecular biology, microbiology, cell biology. Harvard PhD, awarded best dissertation from the Harvard School of Public Health. Highly collaborative and motivated to pursue excellent science to improve human health.
Analytical Strategy, US Biologics
- Analytical Strategy Lead, autoimmune CAR-T program, achieved First in Human - Team Lead, Molecular Biology & Microbiology - Team Lead, Cellular Analytics - manage multiple academic and external collaborations (new technology development) - IND, IMPD, INDa, sNDS filing experience - Matrix, cross-functional leadership across Analytical Development, Process Development, Product Quality, Quality Control, Regulatory and CMC - method development, phase appropriate validation, method transfer, method comparability to enable clinical release and characterization testing, compliance, GMP requirements, regulatory guidelines (ICH, FDA, Ph.Eur., JP), change controls - stability studies, reference material establishment and trending - control strategy, specifications and justification of specification for clinical and commercial stage programs - digital knowledge and project management skills - member of two corporate culture teams
- Lead, Inflammatory Disease incubator. Matrix lead of cross-functional team responsible for strategy development and deliverables for pre-clinical target. - Lead, Phase III (now commercial) asset mechanism of action working group. Responsible for experimental strategy design and execution, including CRO management. - Project lead on the development of innate immune cell assays, including macrophage signaling and phagocytic responses to gut microbes, to interrogate asset mechanism of action - Project lead on on establishing primary innate immune cell-epithelial cell co-cultures for drug profiling, MoA analyses, and business development - Technical expertise on assay development across multiple therapeutic areas. My work includes primary and immortalized human cell culture in 2D and 3D (monocytes, PBMCs, gut organoids), flow cytometry, transcriptomics, and immune phenotyping. - Contribute data and technical writing to INDs, patents, and for business development - Supervise junior scientist
- Project lead on the development and qualification of a novel whole metagenomic sequencing assay to support the SERES-012/013 (C. difficile Phase III) clinical trial. This work involves cross-collaboration with computational biologists, molecular scientists, validation specialists and quality assurance. - Project lead on the development and qualification of the first biochemical functional potency assays for drug product characterization and release for clinical programs spanning C. difficile, ulcerative colitis, and immuno-oncology - Project co-lead on the strategy and development of novel methods to detect low level abundance of anaerobic organisms in drug product across multiple programs - Project co-lead on the development and qualification of a novel assay that supported initiation of the SER-401 immuno-oncology clinical trial - Developed and qualified microbiological and molecular clinical release and characterization assays across multiple clinical programs, including C. difficile, ulcerative colitis, immuno-oncology, and graft-vs-host-disease - Designed and co-developed novel LC-MS assays to detect biomarkers of interest for SER-109 (C. difficile) and SER-287 (ulcerative colitis) - Contributed writing and data to INDs, generated data for external poster presentations - Managed junior scientists, experienced in method development, validation and transfer, compliance, and regulatory guidelines (ICH, FDA, EMA)
My work investigated the recognition of gut commensal organisms by mammalian innate immune cells, and the consequences of these interactions during healthy or diseased states. This research involved flow cytometry, immunological assays, biochemistry, anaerobic microbiology, primary murine cell isolation and immortalization, cell tissue culture, intestinal organoid culture, and molecular biology. My work brought new experimental techniques and an independent project with a new direction to the lab. I was awarded a three year, $180,000 independent research grant through the Life Sciences Research Foundation. I continued my volunteer science communication work through routine editing of colleague's manuscripts and grant proposals, professional review of manuscripts (on behalf of Dr. Kagan), in addition to writing science pieces for the public.
Resident Tutor in Eliot House, Harvard College. Responsible for a wide variety of scientific and non-scientific mentorship. Sophomore Advisor for Eliot House incoming sophomores, responsible for programming and advising.
My dissertation research examined cell wall synthesis in the bacterial pathogen Mycobacterium tuberculosis and the contribution of distinct cell wall synthesis enzymes to bacterial survival within a mammalian host or during antibiotic treatment. This research involved bacterial whole genome mutagenesis and highthroughput sequencing, microfluidics, timelapse fluorescence microscopy, computational analyses, targeted genetic knockouts, analytic microbiology, murine models of tuberculosis infection, BSL3 level experimentation, and molecular biology. I managed multiple cross-institutional collaborations and won an independent 3 year, $100,000 research grant through the National Science Foundation. I routinely contributed to the broader scientific community, including training users on the departmental fluorescence microscope, leading departmental journal club, editing colleague's manuscripts, grant proposals, and presentations, mentoring younger graduate students, and professionally reviewing submitted manuscripts (on behalf of Dr. Rubin).
I was responsible for generating content for and leading discussion sections of undergraduate students. I generated exam questions, graded exams, and graded student research papers. I mentored students outside of class who required extra assistance.