Experience

Kytopen

• United States
• Biotechnology Research
• 1 - 100 Employee

• Engagement Manager

  • May 2022 - Present



AG Mednet, Inc.

• United States
• Software Development
• 1 - 100 Employee

• Project Manager

  • May 2019 - Aug 2021

  • Manage all activities for configuration and deployment of cGMP and 21 CFR Part 11 compliant clinical trial software designed to collect and process clinical data for FDA adjudication and DSMB workflows.• Review clinical trial charters in collaboration with PI, research, and data management teams for project planning and requirements gathering.• Write technical specification documents translating clinical adjudication workflow requirements into standard specifications templates, tasks, and timelines.• Manage stakeholders, resources, timelines, and budgets across multiple projects.• Develop productive relationships with pharmaceutical clients, CROs, and other vendors, improving reporting of clinical outcomes and growing revenue 39% and total projects 54% y/y.• Work with vendors to integrate multiple platforms for clinical data, including Veeva Systems, Oracle Life Sciences, and various clinical trial sites.• Drive improvement of SOPs and QMS documentation for requirements gathering, client management, trial implementation, and CAPA processes.• Work with product management to improve product features and customer experience for clients in the biopharmaceutical space.• Coordinate with development and quality compliance teams to respond to quality issues, ensuring customer satisfaction and maintaining appropriate regulatory compliance following CAPA processes. Show less

• Associate Project Manager

  • Sep 2018 - May 2019

  • Developed, implemented, and maintained all processes and process documentation relating to deployment SOPs of configurable clinical trial software.• Served as primary project manager for dedicated account, driving over 3-fold growth in account projects.• Provided subject matter expertise on AG Mednet technology offerings, and advised sponsors, CRO's, and clinical sites regarding DICOM, regulatory standards, and product applications.• Oversaw the day to day activities of multiple software application engineers.• Developed training materials tailored to trial-specific workflows. Show less

• Project Management Coordinator

  • Sep 2017 - Sep 2018

  • Assist with all aspects of trial/solutions deployment on AG Mednet product offerings.• Assists project managers in developing and maintaining close relationships with trial managers and investigator sites to facilitate current and future projects.• Respond to users with a high degree of professionalism and accuracy.• Assists with the coordination and the transition from work order signing through trial initiation to facilitate seamless interaction between customers, sales, and operations.• Works closely with business development managers to coordinate account expansion and penetration.• Assists project managers with establishing processes for site adoption including the design of training services and associated materials.• Assist with the development, implementation, and maintenance all processes and process documentation relating to the deployment of configurable end-user products.• Ensure all records pertaining to SOPs are created and maintained in a timely fashion. Show less



Gen9, Inc.

• Greater Boston Area

• Technical Support Specialist

  • Jun 2015 - Dec 2016

  • Managed customer projects from initiation to completion, collecting customers’ technical requirements and managing expectations while delivering products on customer-specific timelines. • Drove the development and adoption of new business processes including customer sample submission, Zendesk customer communications, Zendesk reporting and knowledgebase, voice of customer documentation, and customer order workflow. Changes improved customer experience and increased team efficiency while scaling with >100% y/y growth in revenue and customer base. • Managed a cross-functional team of R&D, manufacturing, and bioinformatics experts including external stakeholders and vendors, e.g. Benchling and Zendesk, to develop a superior customer experience. • Served as adviser to bioinformatics and R&D teams to ensure projects improved customer experience, including critical quality assurance development and containing risk on manufacturing process updates. • Oversaw global bio-security risk management in accordance with governmentally regulated DNA sequences. • Worked in a high-throughput manufacturing lab environment for DNA synthesis utilizing PCR, error correction via filtration, cell culture, mini-prep and other DNA preparation techniques. • Advised customers regarding ideal vector/plasmid design including scarless assembly techniques, CRISPR plasmids, and genome construction. • Utilized negotiation strategies and to expand customer base and increase existing customer value. • Collaborated with marketing and product management groups to develop sales training materials and improve communications techniques within the commercial group to create a consultative sales strategy. • Developed technical language for DNA product specifications, DNA design tools, process documentation, and marketing materials. Show less



Private Tutoring

• Greater Boston Area

• Biology and Chemistry Tutor

  • Jun 2014 - May 2015

  Provided guidance to biology and chemistry students at Boston area colleges and universities, as well as several high school and middle school students. Prepared extra study materials and in depth outlines for essential concepts in biology and chemistry. Provided guidance to biology and chemistry students at Boston area colleges and universities, as well as several high school and middle school students. Prepared extra study materials and in depth outlines for essential concepts in biology and chemistry.



Hamilton College

• United States
• Higher Education
• 700 & Above Employee

• Biochemistry Research Assistant

  • Oct 2012 - Jun 2014

  Researched, learned, and developed protocol for isothermal titration calorimetry (ITC) in studying peptide/membrane interactionsAchieved ITC profiles for piscidin 3 and piscidin 1 that provide important evidence regarding the mechanism of action for each peptideWorked as a senior member of the lab group and introduced new students to the techniques of HPLC, lyophilization, MS, and ITC.Revitalized the Microcal VP-ITC calorimeter at Hamilton College for use in research.Prepared and analyzed samples of peptides embedded in phospholipid bilayers for multiple experiments including neutron diffraction, circular dichroism, and NMRPurified and analyzed peptide samples using mass spectrometry and HPLC Show less

• Biochemistry Tutor

  • Apr 2013 - May 2013

  One-on-one tutoring with students in introductory biochemistry.

• Biochemistry Teaching Assistant

  • Feb 2013 - May 2013

  Assisted in grading exams and assignments.Worked with students on developing a greater understanding of all course materials.



Hamilton College

• United States
• Higher Education
• 700 & Above Employee

• Laboratory Teaching Assistant

  • Aug 2010 - Dec 2010

  Assisted students in experiment setup including preparation of chemicals, technology, and glassware.Troubleshooting of problems in experiment procedures and ensuring students followed procedure to achieve accurate results.Helped students understand the chemistry concepts behind results and observations.Ensured that safety procedures were followed at all times.

• Summer Research Intern

  • May 2010 - Dec 2010

  Performed enzyme kinetics research under the direction of Professor Tim Elgren, focusing on sol-gel encapsultated enzymes using UV-vis spectrophotometric analysis.