Specializing in FDA/OECD Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), human subject research, and biospecimen/biobank management. Extensive experience and passion for mentoring laboratories and organizations to develop robust quality processes and standards for toxicology studies, clinical studies, and biospecimen management. Accomplished in bridging the leap from research to regulatory compliance. Detail-oriented problem-solver and decision-maker with excellent work ethic and high integrity.

Manage the employee donor program, which provides fresh blood and nasal swabs to researchers for pharmaceutical research in Maryland and California. Primary liaison between researchers and collection site, as well as to Principal Investigator and external Institutional Review Board (IRB). Supervise and manage clinic staff. Manage and submit study protocol to IRB, including annual renewal and protocol amendments. Manage program operating manual and write standard operating procedures (SOPs). Plan and implement training of biospecimen requestors. Present quarterly use and budget reports to Principal Investigator. Manage and participate in internal audits and respond to findings. Improve processes as needed. Collaborate with the Safety department to ensure annual bloodborne pathogens and waste management training is completed by researchers.• Co-authored global AstraZeneca standard on employee blood donor programs.• Implemented new training program for specimen requestors, resulting in faster turn-around time for new users to gain access to the program’s cost-saving and research benefits.

Lead efforts in standardizing processes and procedures among all GLP departments, including Maryland, California, and UK sites. Train and mentor others in proper and effective conduct of laboratory procedures to achieve GLP or GCLP compliance. Collaborate with multiple departments to manage projects, including timelines, budgets, equipment repair and maintenance, and documentation of study or equipment deviations. Identify industry trends in FDA/OECD compliance and how they may affect MedImmune.• Spearheaded a cross-functional effort to align terms and procedures surrounding criticality levels of equipment across GMP, GLP, and multiple Facility functions, resulting in faster and more accurate priority setting by Facilities engineers and reducing nonconformance events.• Wrote and implemented multi-site Standard Operating Procedures (SOPs), resulting in increased quality and fewer compliance gaps.• Developed quality systems to align inspection readiness processes across all sites, including the generation of floor plans, list of computerized systems, equipment calibration and qualification processes, preventive maintenance, and security access reports.• Received award for creation of the GLP Histology Laboratory, which allowed GLP studies to be performed in-house with faster timelines and cost reduction.

Plan and direct validation resources and activities to support all GLP laboratories and departments, qualifying all GLP equipment, computer systems, and software across several MedImmune sites. Standardize qualification and change management procedures across all GLP groups; align processes and quality systems with manufacturing (GMP) groups. Advise and participate on teams to decommission sites or relocate GLP laboratories. Supervise and manage validation staff, contracts, budgets, projects and timelines. Continuously review processes and quality systems and seek customer feedback for customer service and process improvement.• Created the department from the ground up. • Developed new processes, standard operating procedures, and an electronic project management and reporting system, resulting in increased efficiency and reduced spending.

Plan, promote, and organize training activities to all US R&D employees on protecting patient privacy and the ethical use of human biospecimens in research, including clinical trial samples. Partner with Business Operations, Legal, Quality Assurance, and Sourcing departments to ensure supplier qualifications meet AstraZeneca quality standards. Provide guidance to R&D groups that analyze clinical trial specimens to ensure compliance with clinical study protocols, Standard OperatingProcedures (SOPs), Good Clinical Laboratory Practices (GCLP), good documentation practices, specimen inventory tracking requirements and any other company policies. Prepare researchers for and participate in internal audits; assist researchers in audit responses.• Developed training module on AstraZeneca standards for using human biospecimens in research, which eliminated training variations and delays and aligned all AstraZeneca sites worldwide.• Researched and implemented sample management database, improving documentation and reducing internal audit findings.• Developed supplier evaluation form to align processes among all AstraZeneca sites and increase efficiency.• Created training video for use by clinical study collection sites on tissue biopsy collection and preservation, resulting in higher quality biospecimen preservation and analytical data.• Co-author of the AstraZeneca global standard on human biospecimens.• Received award for improvements made to the procurement process that reduced timelines for acquiring specimens.

Performed necropsies and recorded findings. Tracked animals from the time of death through diagnosis, and final report. Photographed necropsy cases. Maintained specimen inventory and necropsy facility. Prepared chemical solutions. Analyzed necropsy procedures and facilities and made appropriate changes for more efficient performance. Ensured that appropriate safety supplies and processes were available to staff. Zoo coordinator for ethanol procurement and storage. Performed and supervised entry of all pathology records and reports into pathology databases. Coordinated with external researchers for the disposition of animal tissues for scientific purposes. Set up and maintained new office equipment and software and trained staff and visitors on its use. Recruited, trained, and supervised volunteers.