Jane Rouse, M.S., PMP

Experience

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  Shiekh Zayed Institute for Pediatric Surgical Innovation in Children's National Medical Center

  Jun 2016 - Aug 2016

  Student Innovator

  I provided help on multiple projects within the Bioengineering Department, focusing primarily on rehabilitation engineering, development and creation of various robotic products, REDCap database management, and CITI certified patient interaction. This experience involved me interacting with patients and people of differing fields and backgrounds, and in addition I learned a lot of mechanical and administrative engineering methods and protocols.

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  Control of Miniaturized System Laboratory

  Nov 2016 - Feb 2018

  Team Member

  I collaborated with graduate students, researchers, and fellow undergraduate in order to create magnetic, drug-loaded nanoparticle solutions to be used in a pre-clinical research setting by using sonication, centrifugation, and solutions involving drugs and particles. The research gave me experience in lab work, microscopy, and analytical methods, as well as an insight into the development and testing of new drugs and methods.

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  USDA

  May 2017 - Aug 2017

  NIFA Summer Research Fellow

  I collaborated with a variety of mentors dealing with various agricultural and livestock research. I designed, analyzed, and completed an experiment to test the efficacy of biosecurity measures in a research swine barn. This research gave me exposure to livestock operations, a wide variety of microbiology laboratory techniques, and analytical methods.

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  Leidos

  Jun 2018 - Oct 2019

  QC Analyst

  o Tested utility water samples, including total organic carbon, endotoxin, conductivity, heavy metals testing, and bioburden analysis to ensure sterility of the site water systemo Performed environmental monitoring of clean room environments, including non-viable air testing, microbial viable-air testing, and microbial surface monitoringo Supported ISO Level 5 and 7 (class 100 and class 10,000 respectively) environments during vaccine manufacturing operations to prevent contamination through all phases of the manufacturing processo Analyzed water and product samples for microbial bioburden through bioburden testingo Executed quarterly testing of compressed air and gas systems through non-viable analysis, microbial analysis, and dew point testingo Documented sampling, testing, results, and other facility use within the scope of a Good Manufacturing Practice (GMP) environmento Contributed to internal assessments and external auditso Revised and edited Standard Operating Procedures for site wide protocol and trained peers on procedureso Performed daily laboratory maintenance tasks, including preventative maintenance and cleaningo Organized, designed, and followed protocols for independent investigations to determine root causes of microbial excursionsLaboratory Techniques: bioburden testing via filtration; environmental monitoring; microbial enumeration; gram staining; aseptic technique; serial dilution; colorimetry; bacterial culture Show less

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  Medical Science & Computing (MSC)

  Nov 2019 - Apr 2022

  Formulations Associate Scientist

  o Characterized, formulated, and developed multiple types of biological vaccine candidates, including virus-like particles, monoclonal antibodies, and protein nanoparticleso Executed studies for evaluation and development of stable formulations for vaccine candidates, utilizing a variety of assays to analyze product impact through a variety of stressed storage conditionso Performed study design, sample management, timeline management, data collection, and data presentation for multiple projects o Developed and executed both biophysical and biochemical assays, including absorbance and fluorescence spectroscopy, dynamic light scattering, osmometry, rheometry, pH, conductivity, among otherso Developed methods for evaluation of stable vaccine formulationso Analyzed, interpreted, and presented data in small group, departmental, and conference settingso Wrote and reviewed technical protocols and reports to document formulation, stability, and method development studieso Functioned within an interdisciplinary team to contribute to overall product development and process managemento Efficiently communicated through written standard operating procedures (SOPs), interim reports (IRs), technical reports (TRs), and other forms of documentation for result analysis, experimental reproducibility, and data integrity o Maintained a laboratory notebook with detailed documentation of experimental procedures, protocol, results, and data to ensure data integrity and accuracy of reported resultso Reviewed and verified various reports to ensure accuracy and data integrity Laboratory Techniques: dynamic light scattering (DLS); UV-visibility and absorbance; differential scanning calorimetry (DSC); high accuracy liquid particle counter (HIAC); formulation and buffer preparation; testing for pH, conductivity, osmolality, rheometry, appearance Show less

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  NextCure, Inc.

  Apr 2022 - Sept 2024

  Formulation Scientist III

  ● Designed, performed, and managed formulation development studies and analytical characterization of protein therapeutics● Planned and performed compatibility studies to closely mimic clinical conditions and analyze effect on drug product and substance● Performed studies to determine long term stability of protein therapeutics through a variety of biochemical techniques● Actively contributed to IND filings through development and testing of elaborate experiments, authoring of technical reports and IND documentation, and developed and qualified analytical procedures and drug product and substance specifications● Developed and qualified analytical protocols and methods, including SEC-HPLC and residual DNA by qPCR● Coordinated a team schedule for testing of samples, prepare presentations and data packages, and transfer the information● Managed the development effort for preclinical development of a drug candidate, including working interdepartmentally to collaborate with external partners, rigorous testing and development, and creating and managing the manufacturing Gantt Chart● Functioned within an interdisciplinary team to contribute to overall product development and process management● Communicated and coordinated processes with outside vendors to facilitate proper product development and handling● Coordinated and managed development testing to lead to development and optimization of scale-up manufacturing processes● Functioned simultaneously within a Good Manufacturing Practice (GMP) facility and a development facilityLaboratory Techniques: size exclusion chromatography (SEC); high-performance liquid chromatography (HPLC) ; high-throughput fluorescence; ELISA and residual analysis (Protein A, Host Cell Protein) residual DNA by qPCR; thermal stability characterization; UV-visibility and absorbance; compendial testing for pH, osmolality, appearance, endotoxin, High Accuracy Liquid Particle Counter (HIAC) Show less

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  Vector BioMed, Inc.

  Oct 2024 - now

  Project Manager