Deirdre Daniels, M.S. Email & Phone Number

Carlsbad, California, United States

Helping customers design, develop, and manufacture quality products that are compliant with regulations.

Greater Chicago Area

Provides expertise in in vitro diagnostic product development, including assay development, device development, device integration, design control, manufacturing transfer, V&V, quality management, as well as clinical and regulatory.

Springfield, Missouri Area

Provides product development expertise to companies developing in vitro diagnostic devices. Areas of expertise include molecular assay development; design control; analytical methods; V&V; stabilization of reagents through lyophilization; process development and improvement; program, personnel and laboratory management.

V&V | Medical Devices | Design Control | Regulatory Adherence

Leads cross-functional scientific teams while adhering to strict regulatory guidelines. Provides subject matter expertise to early-stage and growing IVD companies.

Athens, Ohio

Managed a project team of 10 staff consisting of scientists, engineers and technicians in the development of a quantitative assay for a point-of-care molecular diagnostic device. Responsibilities also included managing all administrative tasks for the entire R&D department, including laboratories, in the Athens facility. • Adhered to project milestones and budget by effectively directing technical tasks of a cross-functional product development team thus improving return on investment for the organization• Overhauled new employee training program which increased time spent with hands-on training and improved overall performance of new employees• Implemented a 12-week summer internship program for the R&D group in Athens by securing funding, interviewing candidates, coordinating training and ensuring mutual benefit for both the candidate and the organization by providing a labor cost savings and potential future revenue• Reduced operating costs by revamping processes for inventory of equipment and consumables thereby eliminating redundancies

Athens, Ohio

Led multiple R&D project teams simultaneously in the development of immunological and molecular diagnostic assays. Responsibilities included building, training and motivating teams of 3 to 4 people to produce high quality data on time and within budget.• Achieved CE mark and FDA approval for 3 molecular diagnostic assays thereby increasing annual revenue for the organization• Streamlined internal data reporting and auditing which resulted in more efficient FDA 510(k) submission process• Implemented a data management process eliminating loss of critical analytical and clinical data thus improving overall quality management• Managed the investigation and determination of root cause for assay failure during development of a quantitative PCR assay for a point of care molecular diagnostic device resulting in a higher quality product design• Decreased turn-around time for contracted services for projects by improving vendor management

Kansas City, Missouri Area

Managed programs for government and industry which included tasks such as proposal production, generating and managing budgets, generation of study protocols and in-lab procedures, scheduling of resources, managing and analysis of data, client management, and report generation. • Effectively led a team in the analytical evaluation of Influenza point-of-care diagnostic prototypes resulting in a follow-on contract and additional revenue• Successfully led a team in the analytical verification and validation of DNA extraction kits and PCR assays for a medical device company, which resulted in additional work involving similar studies, one of which was ultimately approved by the FDA for in vitro diagnostic use

Master Of Science (M.S.), Biology, General

Studied microbiology and immunology. Masters thesis: "The production of nitric oxide by murine peritoneal and alveolar macrophages.

Bachelor Of Science - Bs, Biology, General

Activities and Societies: Gamma Sigma Sigma community service sorority | Honors Society | Pride Marching Band | Flute choir | Resident.