Elisa Lange Email & Phone Number

New Berlin, Wi, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

• Monitored, compiled, and reviewed analytical and QC data (qPCR, ddPCR, in-vitro based assays, ELISA, SDS-PAGE, HPLC, MS, Western Blot, and compendial methods) individually and with team members.• Reviewed protocols, methods, reports and CoA/CoTs for release and stability of AAV based gene therapy products generated at CTLs/CMOs, and internally at Sarepta.• Managed and communicated QC Review Team activities to ensure alignment with lab testing schedules and target Drug Product lot release and stability priorities.• Assisted in writing and reviewing quality documents such as SOPs, Quality Events, Deviations, Investigations, OOS/OOT, CAPAs, and Change Controls originated internally as well as at the vendor sites. • Assisted Analytical Development and Quality Control team with coordination of sample pulls, set downs, and tracking of critical reagents.• Supported method development, transfer, and qualification/validation activities associated with the release of bacterial plasmids, viral vector products, critical reagents, and reference material. • Trended data for qualified materials, release products, and stability products.• Assisted in the review and compilation of data to support regulatory submission and internal audit readiness.• Reviewed and approved monthly FTE invoices of CTLs/CMOs and ensures any accruals are within the annual fiscal budget.• Processed CTL/CMO quotes and letters of agreement to generate POs to support method development and validation needs.• Coordinated analytical method transfers and international shipments of samples and materials for development and validation activities.• Was the team lead for developing and implementing Sarepta’s flagship, lab-based cGMP/GDP Training program, to bridge QC as part of ongoing QC process improvements.• Assisted in the review, creation, and implementation of an electronic documentation system to replace paper notebooks.

Somerset, Nj, Us

• Was responsible for the interface between client, operations, and business development to build strong relationships, obtain repeat business, or enhance scope of current projects.• Built and lead project teams to support successful process development and clinical manufacturing.• Managed the execution of the client’s requirements in accordance with agreed upon program activities to achieve established goals and deliverables.• Documented program progress with MS Project timeline and facilitated risk assessment/mitigation as needed.• Monitored revenue recognition and ensured that key milestones were achieved with on time delivery. • Reviewed and authored contracts and change orders.• Lead site visits for current and prospective clients.• Coordinated shipment of samples and materials for development and manufacturing needs.

Wilmington, Nc, Us

• Was the Technical Project Manager (TPM) and Subject Matter Expert (SME) for method feasibility, validation and application including: protocol and method development, method qualification and validation, report generation and release, controlled document authorization, data review and assay execution.• Was the TPM and SME for routine sample testing including: scheduling project testing, participating in teleconferences, generating reports, and evaluating resources and timelines to support cGMP testing of biopharmaceutical products.• Collaborated with teams across campus to increase client testing efficiency and improve processes within cGMP compliance. Led the successful training of junior and senior analysts for the transfer of multiple residual DNA methods to support client projects and manage testing volumes.• Was the lead analyst in the successful method feasibility, transfer and validation of a cell-based infectivity assay for gene therapy products in compliance with international and USP guidelines; 100% pass rate.• Was a SuperUser for Workbook. Assisted in innovating and implementing an electronic documentation software to replace paper notebooks. Was a regular source for troubleshooting and trainer for new users.• Regularly led process improvement projects and 5S system implementation/maintenance.• Professional development programs:LEAD – Nominated for and completed the 2020 Emerging Leader Program - a mixed mode (e-learning, videos, workshops and mentor/mentee meetings) program that provides baseline training and mentorship to prepare those identified within the company as potential people leaders to effectively manage and lead others.

Wilmington, Nc, Us

• Was responsible for scheduling routine sample testing of residual DNA quantification for multiple projects while ensuring the team meets testing volume and timeline expectations.• Was the Subject Matter Expert (SME) for a variety of complex sample preparation and analysis procedures to quantitatively measure biopharmaceutical gene therapy compounds in compliance with SOPs and cGMP regulations. Results generated and reported were on time and at the highest of quality by continuously maintaining or improving performance regarding Quality Control/Quality Assurance metrics.• Followed validated or experimental analytical procedures and was responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications to generate certificate of analyses for clients under cGMP regulations. Authored and executed nonconformances and large-scale investigations as necessary.• Certified for quality review of data and providing training on qPCR and cell-based assays.• Technical skills: Real Time qPCR (RT-qPCR), ddPCR, DNA extraction (manual and automated techniques), cell culture, cell-based assays (serum performance testing, infectivity and potency), aseptic/sterile technique, environmental monitoring, plasmid DNA standard preparation, gel electrophoresis, spectrophotometry, assay development and method validation, quality review of documentation, report release, cGMP compliance, and project management.

Wi, Us

• Assisted in the design, execution and analysis of experiments involved in the study of atherosclerosis by demonstrating strong critical thinking, problem solving, and attentiveness to detail • Evaluated and interpreted validity of data from ongoing projects in regular meetings with principle investigators and other research staff• Experiments/analyses performed: microarray analysis, RNA isolation/purification, cDNA synthesis, primer synthesis, RT-PCR, gel electrophoresis, thioglycolate-illicited peritoneal macrophage isolation, total peripheral blood mononuclear cell isolation, Lowry protein assay, total protein extraction, western blot, SDS-PAGE, PFO-PAGE, RNAseq mRNA library synthesis and analysis, lipid raft isolation, Co-Immunoprecipitation, cell culture and transfection.

Wi, Us

Fort Worth, Texas, Us

• Mastered the electronic medical record and medical terminology• Trained, evaluated, and graduated prospective trainees at Scribe University and trainees on site• Audited active scribes’ charts for quality feedback and quarterly performance evaluations• Accurately documented patients’ electronic medical record in real-time for emergency department physicians and physician assistants• Efficiently recorded patients’ medical history and chief complaints, transcribed physical exams, reported diagnostic test results, prepared plans for follow-up care, and documented directly from the conversation between physicians and patients

Greenfield, Wisconsin, Us

• Effectively scheduled appointments in order to optimize patients’ satisfaction and provider time. • Obtained revenue and maintained patient accounts by recording and updating personal and financial information, recording and collecting patient charges, controlling credit extended to patients, and expecting third-party insurance claims. • Efficiently managed multiple tasks with frequent interruptions to meet various needs and requests of patients, doctors and other staff members while ensuring professional and courteous services.

Master’S Degree, Medical Sciences

Bachelor’S Degree, Physiology