Ashlee Schramm Email & Phone Number

United States

Boston, Massachusetts, United States

- Leads multiple studies supporting the tech transfer of critical pivotal process changes to manufacturing such as optimizing electroporation procedures and comparability studies- Formulates and leads process characterization and process improvement projects for Immuno-Oncology therapies utilizing CRISPR/Cas9 technology- Analyzes data from design of experiment (DOE) studies in JMP statistical software and presents findings cross-functionally- Representative for Process Development… Show more - Leads multiple studies supporting the tech transfer of critical pivotal process changes to manufacturing such as optimizing electroporation procedures and comparability studies- Formulates and leads process characterization and process improvement projects for Immuno-Oncology therapies utilizing CRISPR/Cas9 technology- Analyzes data from design of experiment (DOE) studies in JMP statistical software and presents findings cross-functionally- Representative for Process Development in Safety & Compliance Recognition Tool Development Team- Facilitates weekly department meeting in project and lab management: delegating tasks, aligning on best practices, and coordinating lab maintenance activities - Follows and ensures current GLP, GMP, and GDP practices Show less

Cambridge, Massachusetts, United States

- Supported team responsible for authoring BLA submissions of two late-stage severe genetic disease drug products (eli-cel & beti-cel) and responses to FDA information requests - Authored change control impact assessments in collaboration with other cross-functional stakeholders - Collaborated cross-functionally to complete authoring of regulatory submissions - Representative for Process Development on CMC team, compiling and maintaining master spreadsheets of clinical data -… Show more - Supported team responsible for authoring BLA submissions of two late-stage severe genetic disease drug products (eli-cel & beti-cel) and responses to FDA information requests - Authored change control impact assessments in collaboration with other cross-functional stakeholders - Collaborated cross-functionally to complete authoring of regulatory submissions - Representative for Process Development on CMC team, compiling and maintaining master spreadsheets of clinical data - Key stakeholder for Process Development in cohabitation of shared lab space - Oversaw and maintained team compliance on all required trainings as assigned Training Coordinator Show less

Cambridge, Massachusetts, United States

- Designed and executed process characterization experiments involving the isolation, transduction, expansion, and cryopreservation of gene-modified hematopoietic stem cells- Designed experiments utilizing design of experiment (DOE) or one-factor-at-a-time (OFAT) methodology- Analyzed, interpreted, and presented statistical data using JMP- Managed core/banking requests to drive completion of at-scale drug product generation for cross-functional activities- Trained new colleagues… Show more - Designed and executed process characterization experiments involving the isolation, transduction, expansion, and cryopreservation of gene-modified hematopoietic stem cells- Designed experiments utilizing design of experiment (DOE) or one-factor-at-a-time (OFAT) methodology- Analyzed, interpreted, and presented statistical data using JMP- Managed core/banking requests to drive completion of at-scale drug product generation for cross-functional activities- Trained new colleagues in lab, and in good manufacturing and documentation practices Show less

Boston, Ma

• Conducted research on strategies to modulate cell signaling pathways as a treatment for cancer• Analyzed blood and tissue samples recovered from patients• Designed and conducted experiments of in-vitro cell lines and collected valuable data using western blotting, qPCR, CellTiter-Glo (CTG), Bright-Glo (BG), and flow cytometry• Presented data on a weekly and monthly basis• Managed laboratory equipment/supplies, regulation compliance, and interacted with… Show more • Conducted research on strategies to modulate cell signaling pathways as a treatment for cancer• Analyzed blood and tissue samples recovered from patients• Designed and conducted experiments of in-vitro cell lines and collected valuable data using western blotting, qPCR, CellTiter-Glo (CTG), Bright-Glo (BG), and flow cytometry• Presented data on a weekly and monthly basis• Managed laboratory equipment/supplies, regulation compliance, and interacted with collaborators• Successfully troubleshooted any problems that may arise in the lab• Organized weekly lab meetings and monthly lunch meetings• Maintained a safe workplace and inspected hazardous waste containers weekly• Remained on-call for malfunctions with lab fridge and freezer equipment Show less

Durham, Nh

• Assisted professor as needed in a BSL-2 Laboratory• Split breast cancer cell line for research project• Stimulated cells with and without siRNA treatment and ran quantitative PCR to determine gene expression• Grew and imaged 3D cells• Helped maintain an organized and stocked laboratory

Durham, Nh

• Troubleshooted issues with projectors, speakers, and additional hardware in classrooms• Spoke effectively and listened attentively over phone and in the classroom• Lead groups of 2-8 technicians in completing daily tasks, including equipment delivery and preventative maintenance• Reported information on hardware issues via Remedy program• Communicated effectively with coworkers and supervisors• Maintained equipment inventory

Portsmouth, New Hampshire

• Designed and constructed DMS boards for asset meetings• Assisted in the decommissioning of an old customer and facilitated communication between document editors and reviewers• Researched and wrote standard operating procedure for equipment• Assisted with pilot runs for another customer• Assisted in ensuring a 6S environment in the office space• Supported employees as needed

Durham, Nh

• Ensured safety of and connected with 30 individuals aged 18-21• Defined and provided for the needs of the hall• Held an honest and respectful relationship with co-RAs and Hall Director• Managed conflict among roommates• Became a role model and mentor for students• Created educational and social programs to teach residents about campus resources• Facilitated group discussion among residents

Woburn, Ma

• Prioritized tasks in a fast-paced environment• Communicated effectively with customers and coworkers• Provided feedback often regarding team effort and the quality of service• Identified and solved problems as they arose• Trained new employees

86 Broadway, Saugus, Ma, 01906

• Provided a welcoming disposition to new and returning customers• Managed afternoon shifts and trained new employees• Paid attention to detail and prioritized tasks in a fast-paced environment• Motivated coworkers in completing daily tasks and quotas

Bachelor Of Science (Bs), Genetics, 3.33 Gpa

Activities and Societies: Phi Sigma, Department of Residential Life, Leadership Camp, Alternative Break Challenge, TRIO

4.34 Gpa

Activities and Societies: National Honor Society, Drama Club, TV Production Club, Calculus Club, Trading Card Game Club, Art Club.