• Prepared dosing formulations, buffer solutions, and maintained study tools including trackers, spreadsheets, and filing systems for in-vivo assay• Supported coordination of operational activities required to manage the lifecycle of test articles, reconciliation of reference standard samples, and final sample disposition via logbook and electronic tracking systems via LIMS• Performed mouse tissue collection, executed DNA Isolation, and genotyping of samples, examined mouse genotype data, manually documented PCR results on controlled forms, and updated genotyping database• Provided support to interdisciplinary quality/regulatory teams to strategize effective action plans for a variety of moderately complex investigations, quality events, and compliance risk assessments (i.e., Deviations/Non-Conforming results, Out-of-Specification / Out-of-Trend investigations or any other quality issue as it relates to gene therapy drug products) to support development projects ensuring alignment with overall departmental and organizational goals• Supported commercial lot disposition by peer-reviewing dosing formulation calculations, and records for completeness• Served as primary injector and executed animal injections for functionality studies, monitored all aspects of animal handling and dosing techniques (cryo-anesthesia procedures, ICV Injection techniques, and post-injection care needs per SOP)• Trained new personnel members on techniques pertaining to in vivo functionality testing. • Assisted in generation and review of new Standard Operating Procedures and study-specific documents.• Provided audit preparation and backroom support for FDA, EMA, and JPMA audits

• Monitored micro/macro-environmental changes in vivarium rooms, ensured all associated equipment/instruments were properly calibrated and/or qualified prior to use, and immediately reported equipment discrepancies, and escalated concerns to appropriate facilities personnel• Accurately collected routine animal weights of on-study animals, logged raw data on controlled QC forms, organized detailed study records in logbooks for data analysis, and QA review• Worked cross-functionally to ensure timely performance of injections of on-study mice to meet commercial lot release schedule deadlines• Proficiently managed the mouse breeding program which included colony maintenance; scheduling of breeding pairs, keeping accurate breeding records, forecasting animal births/output based on study needs, and weaning of mice for future use, conducted standardized animal care training for new / existing team participants, evaluated educational retention, provided performance oversight and development of nine QC In-vivo analysts • Systemized continuous clinical health monitoring of rodent colony; triaged various animal health conditions for sick or wounded animals under the guidelines of Attending Veterinarian and QC Management with minimal supervision• Participated in assigned audit readiness preparation, backroom retrieval of documents, and inspection activities to maintain timely closure of audit cycles• Served as Subject Matter Expert (SME) in in-vivo colony related inquiries during FDA/Regulatory inspections• Analyzed demand patterns for laboratory and in-vivo inventory supply, forecasted inventory levels, served as the point of contact for any correspondence involving timely delivery of materials, ensured communication with QC team on any procurement lead time changes, and/or supply discrepancy findings with internal team members

• Assisted with management of day-to-day vivarium operations, including coordinating with vivarium/husbandry staff, ordering supplies, basic colony maintenance, breeding, and record keeping.• Performed animal tissue collection samples, tattooing, identification, and proper restraint techniques.• Reported any animal abnormalities and/or illness to QC management and veterinary team, and provided animals with continuous environmental support.• Participated in the execution of in vivo study protocols per all study design plans and SOP’s related to study conduct. Responsibilities included: animal weight verification, and data collection either manually or electronically ensuring regulatory compliance with QC vivarium procedures

• Cleaned, organized, restocked work areas, glassware and laboratory equipment (i.e. refrigerators, freezers, and supply cabinets as needed), sterilized equipment, scheduled maintenance for laboratory equipment, and handling of laboratory equipment (centrifuge, micro-pipette, autoclave, incubator, pH meter, etc.) • Prepared, processed, and retained documentation required to maintain DEA-controlled substances license for USDA governed animals, recorded environmental conditions, temperatures, and humidity for an audit ready USDA animal facility• Generated, reviewed, and managed logbooks of vivarium/laboratory departments to ensure that all forms were current and complied with regulations/procedures, performed clinical physical examinations on animals to evaluate health status, and responses to handling and/or manipulation• Provided support to Document Control and Quality Assurance, including document filing and form generation, processed document change requests, prepared documents for Assistant Director approval, and maintained document history files• Prepared chemical solutions, reagents, and performed laboratory tests under the supervision of the Microbiologist in compliance with Standard Operating Procedures • Provided support to facilities to resolve nonconformance issues and identified corrective and preventative actions as related to environmental monitoring excursions, participated in verification and validation of animal assays using standardized procedures and test methods• Performed pre- and post-surgical activities, including cleaning and sterilization of surgical equipment, performed post-op health checks, etc., notified Investigator of altered health status such as reduction in normal behaviors or presence of pain or illness• Performed in vitro laboratory procedures; drug dosing calculations, and administration of treatments (via oral, topical, dermal/epidermal, etc.) under the direction of the Principal Investigator and Attending Veterinarian

• Provided diligent and responsible animal care: changed and cleaned cages; sanitized equipment, administered clinical treatments as directed, facilitated correspondence between principal investigator and facility personnel in regard to animal health• Recorded and/or reported animal abnormalities; including altered eating, drinking, waste elimination, altered behavior, superficial lesions, and/or death, handled particular animals under bio-hazardous waste, and disposal of animal carcasses• Performed technical procedures such as record keeping, animal identification, breeding, preparing diets, and euthanasia, and administered subcutaneous injections as directed by principal investigator• Coordinated, tracked, and managed data management tasks for multiple studies across seven vivarium facilities

• Maintained inventory of pharmacy packages and processed drug shipment: forms, vials, bottles, etc. Received payments from patients• Filed prescriptions in alphanumeric order, photocopy and heavy data entry duties. Received, sorted, and routed confidential patient files, records and prescriptions• Checked patient insurance/billing eligibility via med data system• Recoded insurance and patient data on med data

• Communicated with patients on background, medical and prescription history, insurance information for billing purposes• Deciphered, processed and filled prescriptions accurately and appropriately according to state and federal law.• Responsible for office administration, cashier functions and outstanding customer service• Resolved Third Party Rejections and complete manual claim forms