Douglas Toal Email & Phone Number

Mount Holly, North Carolina, Us

We are using systems-biology tools to discover and commercialize biomarkers that measure soil biology performance and health. Our work promotes sustainable growing practices that encourage environmental stewardship and healthier foods.

Provides consultation and direction to commercial clinical laboratory and biotech operations. Examines current processes and designs changes to ensure elimination of wasteful practices. Formulates and communicates business strategies in high tech medical diagnostic industries. Provides guidance in analytical and clinical validation of diagnostics tests.• Director of a CAP-accredited clinical laboratory performing clinical metabolomics for the detection of inborn errors of metabolism (Metabolon, Inc, Durham, NC). Works closely with key personnel to execute on new test development strategy.• Provides consultation to a biopharma firm in the development of a complex RNA signature to predict response to targeted oncology therapies. Develops product requirement documents, assay validation protocols and assesses RNA expression technologies. • Provides clinical consultative services to a biotechnology firm with innovative and first-of-kind diagnostics test for the diagnosis of Alzheimer’s Disease (SynapsDX, Inc, Rockville, MD). Acting Clinical Director, ensures implementation of quality management systems and established CLIA licensure for the operation. • Provides quality and regulatory guidance to a biotechnology firm (Accelevir Diagnostics, Baltimore, MD) focused on the molecular detection of low copy HIV in patients. • Provides Clinical Director oversight to clinical laboratories performing PCR testing for SARS-CoV-2. Works with management and staff to implement best practices and ensures compliance with regulatory authorities.• ABMM board certified Clinical Director providing support to a biotechnology Firm (OpGen, Inc) focused on the molecular detection of hospital-acquired infections using proprietary and first-in-class Microfluidics technology. Released patient reports and consulted with ordering physicians, collaborated with leading scientists to effect technology transfers. Promoted adoption of technology to Key Opinion Leaders.

Morrisville, Nc, Us

Responsible for the oversight of Clinical lab commercial operations, management of personnel, maintenance of regulatory standards and overseeing the development and operations of the current facility and build-out of future laboratory space. Supports Metabolon’s objective of developing and providing metabolomic-based tests for the management of patients with metabolic diseases. Oversees the validation of metabolomic-based technologies in a CLIA-regulated environment. Allocation of resources and implementation of production plans in order to meet rapid turn-around times while ensuring the highest level of quality.

Managed all operations within the U.S. including Laboratory (Microbiology and Safety), Specimen Receiving and Client Support. Responsible for developing and implementing strategies, programs, systems and processes to support and build Eurofin global central laboratory services. Led in the development and harmonization of a global central laboratory business through interactions with Client Support, Sample Reception, Laboratory, Business Development, Information Technology, Data Management, and Project Management, and any other operational units vital to running the Laboratory business. Ensured compliance with CLIA, GCP, and CAP guidelines and participated in client and regulatory body audits. Worked to resolve problems within the struggling operational departments and within six months of promotion into this position all departments achieved Key Performance Indicator objectives.

Managed all Microbiology operations within the U.S. and was responsible for developing and implementing global strategies to grow the microbiology businesses throughout the world. Responsible for ensuring quality of services through standardization of SOP’s and training of all global staff. Worked with Business Development to establish pricing and opportunities within the biopharma industry. Worked with internal and external Information Technology resources to improve systems and to increase customer value by elimination of wasteful processes. Interacted with clients to resolve problems and to introduce new services. Responsible for the financial performance of the Microbiology business in the U.S. Within the first year of employment cut costs and improved processes to realize two years of positive margin after several years of loses. Started a molecular biology and virology laboratory to introduce new services to clients and improve revenue.

Lancaster, Pennsylvania, Us

Supervised laboratory management personnel across four locations in the eastern U.S. and provided guidance and direction as needed. Responsible for ensuring compliance and integration of facility operations with corporate and regulatory policies and procedures. Reviewed and approved Quality Assurance SOP’s for facility and ensures their implementation so that the facility is operated in a compliant manner. Maintains close interaction with key accounts and all project management personnel to ensure customer satisfaction. Responsible for maintaining positive operating margin at 25% or greater to the company and for meeting and exceeding the annual budget.

Lancaster, Pennsylvania, Us

Managed a 40 person microbiology laboratory with revenues exceeding six million dollars and profit margins of +30%. Administered operational changes to realize significant efficiencies through improved quality systems and information technology upgrades. Realigned management structure to promote star performers and reinforce lines of authority and accountability. Introduced employee recognition and rewards to improve staff retention, productivity and morale. Ensured compliance and integration of facility operation with ISO 17025 guidelines and corporate policies. Responsible for maintaining positive operating margins and meeting or exceeding the annual budget.

Lancaster, Pennsylvania, Us

Managed a start-up microbiology laboratory to provide positive operating margin for the company and meet annual budgetary goals. Built and maintained positive customer relationships and sales growth through direct interaction with customers and sales personnel. Reviewed and approved Quality Assurance SOPs for the laboratory and ensured their implementation. Provided periodic reports to the General Manager to ensure that goals and objectives were achieved and to recognize opportunities for development. Participated in business team activities to develop and implement sales strategies to ensure budgetary goals are achieved. Directed R&D to develop new and sensitive testing methods for the detection of microorganisms in environmental samples.

Led an entrepreneurial team effort to create and maintain an online research tool for scientific companies and institutions that are in the market to purchase laboratory equipment. Consulted with clients on purchasing needs, developed and directed client services, coordinated efforts of outside software companies, consultants, and network engineers. Built a solid client base by identifying and focusing on relevant problems facing our customers.

Directed the Bacteriology, Virology, Mycology, Molecular Biology, and Mycobacteriology Laboratories of a top ten Medical Reference Laboratory. Responsibilities included establishing and enforcing standardized testing policies, introduced new and cutting edge technologies into the testing regime, acting as liaison and consultant with physician and nurse clients, and ensuring reliable service through extensive Quality Assurance Programs. Led a staff of forty Medical Technologists and Laboratory Assistants. Acted as the expert in infectious disease laboratory diagnosis for the company.

Rochester, Minnesota, Us

Received training in all aspects of Clinical Microbiology including the latest in clinical diagnostic procedures, infection control, infectious disease management, public health laboratory, assay development and validation, and diagnostic decision-making. Developed and validated new molecular diagnostic testing methods for pathogenic viruses. Provided mentorship and guidance to a junior Postdoctoral Fellow during the second year of tenure.

Assured the quality and safety of Allergy Laboratories products by conducting tests for contaminants. Performed particle and bacterial contamination testing using clean rooms and production room surfaces

Phd, Microbiology

M.S., Microbiology

B.S., Biology