Overall responsibility and oversight of BIOQUAL’s Quality Assurance Unit (QAU) and Training Department. Led comprehensive effort to achieve GLP compliance at BIOQUAL. Performed a significant overhaul of QAU responsibilities and auditing procedures to align with GLP CRO industry standards and best practices. Expanded QAU services to include protocol, process, critical phase, raw data, facility, final report, and vendor qualification audits. Significantly updated BIOQUAL’s Good Documentation Practices SOP and training program to improve the quality of raw data and to ensure compliance with GLP regulations and industry best practices. Ensured that training files for all study personnel include all GLP-required documentation of experience and proficiency. Implemented an SOP style guide and SOP template to standardize company SOPs and created an effective periodic controlled document review process. Significantly increased (10-fold) throughput of controlled document revisions through the effective use of software tools and process controls. Ensured SOP accuracy for all critical technical processes via process (SOP) audits. Established a GLP-compliant deviation reporting process. Established GLP-compliant study protocol and final report templates. Facilitated GLP training for Study Directors, technical staff, and QAU personnel via an independent QAU consultant. Designed and facilitated a mock-GLP toxicology study using real animals and test materials (Gatorade powder) to identify process gaps and ensure facility readiness for GLP-compliant studies. Led in-house validation project for Adobe Acrobat Sign and eLab sample management software to ensure compliance with 21CFR11. Ensure QA monitoring of all regulated (GLP) studies and many non-regulated studies as requested by management or quality agreements. Host regulatory and sponsor audits and make recommendations to management to address deficiencies. Assign and monitor daily projects for the Quality Assurance Unit.

Responsible for directing the operations of the Small Animal Division of BIOQUAL’s preclinical contract research program. Duties include ensuring prompt and efficient scheduling and successful execution of multiple concurrent studies focusing on in vivo models of infectious disease including AIDS, influenza, and coronavirus, under ABSL-2 and ABSL-3 containment. Led multi-year effort to significantly increase the throughput and quality of execution of small animal research projects. Increased division size from under 10 staff members to over 40 talented caretakers, technicians, maintenance staff, and managers across two facilities. Developed a proprietary scheduling tool that tracks daily effort for over 150 studies at a time, enabling quick and efficient scheduling of multiple concurrent study designs across multiple facilities and functional areas. Revised pricing models to accurately represent true effort based on metrics and actual supply costs. Led division through a successful AAALAC Re-Accreditation and multiple client audits. Work closely with internal and external customers to come up with creative solutions to achieve their research goals. Ensure that staff are properly trained at all levels and adhere to company SOPs and federal regulations.

Responsible for managing the operations of the preclinical contract research program at SoBran’s large and small animal facility in Browns Summit, NC and the small animal facility in Baltimore, MD. Duties included planning, organizing, and ensuring the successful execution of multiple complex preclinical GLP and non-GLP contract research studies, as well as mentoring and developing management and technical staff. Responsible for ensuring technical proficiency of all staff and that all activities are conducted in compliance with the Guide, the AWA, GLPs, study protocols, and facility SOPs. Other duties included authoring and reviewing SOPs, data collection forms and study protocols, and implementation and maintenance of GLP-validated data collection software (Pristima). Worked to prepare the NC facility for AAALAC accreditation, and to maintain accreditation status for the Baltimore facility. Developed numerous processes and software tools to improve efficiency and quality at both facilities, including an Excel-based system to replace TOPAZ software at both facilities, saving the company over $30K annually.

Contract Facility Manager of the nonhuman primate facilities at the Division of Veterinary Resources, National Institutes of Health. Responsible for managing 25 people across 4 buildings, including cagewash, animal caretaker, administrative, and supervisory staff. Duties included ensuring the care and well-being of over 1,000 old world and new world NHPs and coordinating with Investigators and technical groups to facilitate successful study execution. Assisted with the efficient allocation of the budget and maintained the inventory of all feed and supplies. Ensured compliance with OSHA, PHS and USDA regulations, and internal Standard Operating Procedures. Hired, developed, and promoted staff. Developed animal census and billing system which greatly improved the efficienct of monthly billing and animal tracking. Led facilities through multiple successful ACUC inspections and AAALAC re-accreditation.

Contract Facility Manager and ICU Lead Veterinary Technician of Building 28, Division of Veterinary Resources, National Institutes of Health. Responsible for managing 13 people, including animal caretaker, administrative, technical, and supervisory staff. Duties included ensuring the care and well-being of multiple species, including rodents, dogs, swine, sheep and ferrets, as well as leading the DVR Intensive Care Unit, which provides critical care for pre- and post-operative surgical cases and spontaneously ill animals for all DVR facilities, including NHP areas. Assisted with the efficient allocation of the budget and control the inventory of laboratory and pharmaceutical supplies. Ensured compliance with OSHA, PHS and USDA regulations, and internal Standard Operating Procedures. Developed pharmacy and supply inventory control system, an automated husbandry log generator, and numerous other software tools to improve efficiency and quality in operations and reduce waste. Led facility through multiple successful ACUC inspections and AAALAC re-accreditation.

Responsibilities included facilitating training classes for a contract of over 130 personnel including administrative, cagewash technicians, animal caretakers, veterinary technicians, and managerial staff throughout 8 facilities at the Division of Veterinary Resources, National Institutes of Health. Conducted new hire orientation and monitored the progress of employees during probationary periods. Performed continuing education and training, including hands-on proficiency training. Created a full set of narrated PowerPoint presentations for the ALAT exam that are still used by the training departments across many of the SoBran animal contracts throughout the country. Prepared and presented materials for the SoBran LATG prep course.

Managed operations for the animal research laboratory at Human Genome Sciences, under contract by SoBran. Responsible for animal welfare, supervision of SoBran technical staff, regulatory compliance, and fulfilling all other SoBran contract requirements. Assisted in setup of new animal facility. Championed a variety of process improvements such as a Microsoft Excel-based automated cage card creator with integrated animal tracking and lab supply inventory control system. Worked with HGS management to create SOPs for animal husbandry and technical procedures. Provided technical training sessions for HGS research staff and SoBran technical personnel. Assisted HGS management with various departmental projects and initiatives. Provided technical and logistical support for Principal Investigators and department managers.

Served as head technician, managing multiple concurrent GLP studies for a contract research organization. Responsible for scheduling technical personnel, overall study management, technical procedures such as dosing and clinical sample collection, and GLP data collection and review. Proficient with a large variety of technical procedures on small and large laboratory animals, including nonhuman primates. Provided technical training for new technicians. Created numerous standard operating procedures as well as controlled forms, many utilizing MS Excel formulas and macros. Assisted in authoring study protocols. Completed many Lean Six Sigma process improvements as a certified Green Belt.

Performed gross necropsies on large and small laboratory animal species. Skilled in a wide variety of tissue collection and sampling techniques, including OCT and microscopic ocular tissue dissection. Proficient in describing macroscopic tissue abnormalities. Experienced in reproductive toxicology and fetal examination techniques, including Hamilton-Thorne Sperm Motility Analysis and fetal visceral examination. Trained newer technicians on a variety of technical procedures.