Christopher Slachta, Ph.D., M.B.A. Email & Phone Number

United States

Cytovale®, is a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases

Des Plaines, Illinois, United States

P+L responsibility and oversight for operations and supply chain activities for up to $1.4 billion in sales, $400 million (6,700 SKU and 700-plus finished goods) sold across 160 countries. Maintains $75 million annual capital budget. Led operations readiness activities for launch of Alinity m platform, including instrument manufacturing readiness (with third-party manufacturer), supply agreements, internal assay manufacturing readiness, capital planning, facilities expansion, large-scale lyophilization, fermentation, and bulk formulation capacity. Guided staff of seven direct reports with global responsibilities. Assumed direct and matrixed leadership of up to 625 personnel. Fostered and led end-to-end supply chain activities: procurement, planning, warehousing distribution, manufacturing, facilities, EHS, operational excellence, technical support for assays and devices, and GMI improvements. • Led COVID-19 assay manufacturing emergency production ramp-up, representing 400% capacity increase in less than 60 days. Delivered 1.4 million weekly SARS-Cov2 assays for use on m2000 and Alinity m molecular diagnostics platforms. Managed Alinity m instrument ramp-up from 230 to 420 instruments per year.• Improved supply chain performance and led initiatives to drive sustained 97% reduction in back orders globally.• Delivered $22 million in gross margin improvement annually.• Created integrated business process to drive supply continuity improvement projects and gross margin projects in manner that best allowed resource flexibility via cross-functional prioritization.• Led development of CDx business team, generating $20 million in high-margin revenue.• Developed organizational capabilities to reduce manufacturing process risk and improve product launch risk management files. Yielded zero FDA 483 Observations while facilitating substantial reduction in global field actions, resulting in award of Abbott Quality Plant of Year for 2019 and 2020.

Lake Forest, Illinois, United States

Maintained responsibility for global external manufacturing and technical operations representing $3.5 billion in sales. Assumed supply chain responsibility for all assay external manufacturing (ten major third-party manufacturing suppliers) to include managing cost basis of $80 million across contract manufacturing network in EU, Asia-Pacific, Canada, and U.S. Supervised 600-plus global personnel (indirect labor for manufacturing support, on-market technical and scientific production, customer quality support, process validations, corrective and preventative action implementation, and margin improvements). • Named winner of 2017 President’s Award for leading product launch activities associated with new Alinity I and c platform. Led all operations and commercialization activities for 183 new Alinity diagnostic assays / reagents, calibrators, and controls through both internal and external manufacturing networks.• Led cost and quality improvement initiatives to yield $7 to $8 million in annual cost and efficiency improvements. Guided Lean activities to improve order fill rates by 97%, decrease back orders per year, and slash overall product performance field actions.• Drove development of global organization to include emerging markets in Russia, Brazil, and China, with operations resources aligned to customer service and commercial initiatives. Facilitated reduction of investigation reaction time by 30% and reduced total complaint rates by 65%.• Implemented and enacted enterprise operations design transfer community of excellence for internal and external manufacturing operations to meet product design requirements while ensuring use of reproducible and robust manufacturing best practices during design transfer to operations.

Raritan, New Jersey, United States

Operated as general manager for five Johnson and Johnson medical devices and diagnostics manufacturing sites, including Raritan, New Jersey (transfusion medicine and aseptic pharmaceutical finishing); Huntingdon Valley, Pennsylvania (cellular and molecular diagnostics); Buffalo, New York (plasma donation and processing); and Pompano Beach, Florida (immunohematology manufacturing). Delivered transfer of high-throughput manufacturing line to alternate site (new ID-MTS Gel Card manufacturing line) to help yield $2.5 million in operational efficiency gains.

Raritan, New Jersey, United States

Assumed responsibility for team of 150-plus scientists and engineers and 12 direct reports located in Raritan, New Jersey; Rochester, New York; Pencoed, Wales; and Pompano Beach, Florida. Oversaw all aspects of post-launch technical and scientific production and customer quality support, process validations, and corrective and preventative action implementation. Led relocation of Veridex assay manufacturing operations with associated facility, equipment, and process validations, contributing to $2.2 million in operational efficiency gains. Guided cross-functional global team to update process validation compliance across multiple product lines.

Raritan, New Jersey, United States

Maintained accountability for value streams associated with three major Immunohematology diagnostics product lines: reagent red blood cells, Antisera, and BioVue column agglutination blood banking technology. Led and managed four direct reports, 45 indirect reports, and 12 contract employees. Facilitated management of 24x6 production operations in FDA-regulated cGMP-cGLP facility. Managed and executed cost improvement and waste reduction projects for a manufacturing facility, accounting for $5.5 million in annual savings. Implemented process for cross-training technical personnel within plant to gain efficiency.

Raritan, New Jersey, United States

Acted as site leader for product support-technology transfer (triage, immunohematology, RhoGAM, and donor screening) as part of worldwide product support organization. Led all aspects of business and technical support for 50-plus domestic and internationally distributed products (both field and operational support). Project managed multiple concurrent projects associated with product failure investigations, factory non-conformances, root cause analysis and implementation of corrective and preventative actions, and process and material validation.

Pennsylvania Army National Guard

Maintained multiple battalion staff positions as well as executive officer and platoon leader. Led 254 soldiers and officers and facilitated management of $20.5 million in military equipment. Named as honor graduate of infantry mortar leaders course. Earned Army Commendation Medal (two awards), Army Achievement Medal (two awards), Armed Forces Reserve Medal, Army Reserve Component Achievement Medal, and Armed Services Ribbon. Received honorable discharge.

Philadelphia, Pennsylvania, United States

Fostered general clinical laboratory assays, pre-transfusion blood compatibility testing, clinical urinalysis, hematology, and microbiology procedures. Acted as transfusion services coordinator to trauma response team. Provided reagent and equipment quality control. Maintained inventory control.

Philadelphia, Pennsylvania, United States

Facilitated planning, organization, and cryopreservation of patient bone marrow and peripheral blood stem cells for autologous bone marrow transplantation (50 to 70 patients per year). Coordinated donor / recipient HLA testing for heart, kidney, and bone marrow transplantation programs. Supervised and trained 20-plus personnel and pathology residents in CLIA-certified laboratory. Developed and implemented cost-effective program to reduce incidence of platelet refractoriness in pre- and post-bone marrow transplant patients.

Doctor Of Philosophy - Phd, Molecular Immunology And Microbiology

Executive Mba

Post-Doc, Virology And Immune Tolerance

Bachelor Of Science - Bs, Clinical Laboratory Sciences