Joseph Kessler Email & Phone Number

Cincinnati, Oh, Us

Consultant services offering expertise with laboratory and biorepository operations in a regulated environment as well as associated business development. Includes onsite evaluation of end to end biorepository processes for efficiencies and compliance appropriate for inspection/audit readiness and CAP Biorepository preparedness

Covington, Ky, Us

Responsible as the operational leadership and direction for the development and growth of global biobanking services within Medpace. Efforts include integrating and standardizing biobanking service capabilities across business and therapeutic areas within the organization. Responsibilities include developing internal efficiencies and best practices, establishing strategic partnerships with industry sector leaders through execution of particular operational, clinical trial management and regulatory compliance efforts. Also ensures cross-functional and global coordination of biobanking services, while aligning the vision and strategy of Medpace Executive Team.

Provide immediate, on-the-ground practical effort for establishing and maintaining operations supporting clinical testing and biobanking. Includes establishing gap analysis of organizations, efficiency evaluations, oversight for project management for remediation activities, assessment of quality management to ensure fit-for-purpose, assay validation experience and facility preparedness.

Morrisville, North Carolina, Us

Responsible for the day-to-day activities of the company (i.e., US and China facilities), which include operations (e.g., facilities, logistics, materials/sample life cycle management, environmental health and safety), as well as oversight for all customer-facing activities (clinical trial genomic services and biorepository services). Also responsible for implementing strategic initiatives and program management in conjunction with the Chief Executive Officer to provide for high performance and growth of the company.

This position involves the oversight of clinical testing and sample repository services for DaVita. Responsibilities also include complete oversight of clinical sample processing and sample management of multiple intra-company and external client studies established. Technologies include clinical chemistry, hematology, microbiology as well as other sample processing capabilities, with automated platforms. Oversight responsibilities for 6 direct reports (200+ staff).Accomplishments and duties:* Oversight for two core CAP/CLIA laboratories as well as hiring site Directors of Operations* Developed test plans for various internal proof of concept studies and ensured regulatory compliance for evaluating analyte reference ranges, analyte stability, validating shippers and shipper re-use, temperature monitoring from logistics through specimen life cycle. * Installed Laboratory Support group and developed procedures to ensure qualifications of biorepository Controlled Temperature Units and laboratory instruments as per GCLP. Significant savings were realized since activity was no longer outsourced.*Performed thorough gap assessment of current clinical study (i.e., central lab) services and implemented procedures, which established clinical processes and managed favorable client relationships f or multi-million dollar services.*Developed organization and hired experienced staff to support ongoing sponsored studies for various early and late phase trials. This ensured fit for purpose quality through clinical processes.*Acting subject matter expert for qualifying external vendors as suitable third party laboratories *Created and instituted efficient processes within biorepository, which included compliant procedures, a modified freezer racking system, developing periodic QC testing of inventory system, and better integration of practices through sample intake to storage.

Director in Vaccine and Biologics Laboratories at PPD. Responsible for global specimen biorepository services as well as the Clinical Sample Processing & Management (CSP&M) group, which supports a variety of vaccine, biologics and antiviral clinical trials. B.S. degree in Biology from Slippery Rock State College in PA, and M.S. degree in Biology with an area of concentration in Medical Entomology from Indiana University of Pennsylvania. Research position in the Department of Viral Ophthalmology at The Johns Hopkins Hospital with projects defining the route of infection for ocular herpes, and transmissibility of HIV during corneal transplantation Certification/training at the CDC for isolating, identifying and characterizing HTLV-I, II & III. Research in HIV in the Virus Control Section, under the Office of the Director at NCI-Frederick Cancer Research Facility. Transitioned into a Research Scientist position within the Virology Section, Chemotherapy Dept., Glaxo Inc., RTP, NC. Research Virologist at Merck in 1991, with HIV immunoprophylaxis as well as studies in support of the HIV-1 fusion and integrase. Experience with product release testing using GMP guidelines, and established the clinical sample biorepository. Responsibilities as a Director at PPD included oversight for all clinical testing laboratories within PPD Vaccine & Biologics Laboratories, and most recently his oversight has concentration for CSP&M and PPD biorepository global services. Long, standing member of ISBER (International Society for Biological and Environmental Repositories) and is a co-chair of the ISBER Pharma & Academia Working Group, which is developing alliances between sectors to provide information sharing and standardized guidance across biorepositories. Joe is on the editorial board for the ISBER Journal, Biopreservation and Biobanking and has contributed as co-author for ISBER Best Practices, as well as to the science surrounding quality practices within biorepositories.

Ms, Biology

Bs, Biology

Education record