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Managed manufacturing, operations, logistics, supply chain, purchasing, and process development departments. Managed CMO relationships.Lead new building acquisition initiative and facility design team.ISO 13485 team member

Access Biologicals LLC is an industry leader in the collection and manufacturing of an extensive portfolio of biological products. Our offerings include products and services such as in-vitro diagnostic manufacturing, biopharmaceuticals, cell culture products, and diagnostic research & development.Managed Operations, logistics, warehouse operations, inventory, facilities, purchasing, and testing lab.Oversaw expansion of facilities including new lab space, clean room, warehouse, freezers, and office space.Revamped purchasing process and vendor relations management, realizing significant savings.

Direct company operations and activities of Manufacturing, Operations, Supply Chain, QC/QA, Logistics, Customer Service, and Scientific Services departments, accounting for 70% of overall company personnel.Solidified departmental organizational structure and developed key performance metrics. Examined operating processes and analyzed manufacturing methods via key performance indicators using LEAN principles to accommodate 20% growth. Completely re-designed manufacturing facility and workflow for heightened sterility and efficiency.Was part of due diligence team to prepare company for successful acquisition by Qiagen.At MOBIO/Qiagen, oversaw Manufacturing, Operations, QC/QA, Shipping/Receiving departments. Serve on Order To Cash team and Post Merger Integration teams working with leaders of QIAGEN for successful integration of operations departments. Assisted in consolidation and relocation of manufacturing operations to Qiagen company headquarters in Hilden, Germany.

A start-up focused on life sciences, specifically diagnostic and forensic DNA capture. Hired to establish company infrastructure and realize product commercialization. Worked on device design and prototyping, automation design, manufacturing process design, marketing and website design, business development.

General management of U.S. site of a protein analytical tools company, including manufacturing/QC, operations, logistics, sales, marketing, business development, and G&A. --P&L responsibility for North America--Due diligence for acquisitions--Technology transfer and implementation--Manufacturing efficiency using LEAN principles--Device manufacturing and validation--COGS analysis and metric setting--ERP management and inventory oversight--Sales and Marketing management--Business Development--Logisitics management

As Director of Ops at Assay Designs, managed manufacturing operations, production, QC/QA, packaging, and shipping for ELISA kit business. --Integrated antibody and protein business unit packaging and operations into core operations. --Increased profitability using LEAN principles via effective inventory management and manufacturing efficiency. --Effected a 20% increase in efficiency through extensive cross-training of inter-departmental personnel and bringing automation on-line.Member of due diligence team for successful acquisition by Enzo Life Sciences. As part of Enzo, oversaw Manufacturing and North American Distribution Center operations.--Integrated warehousing operations from different sites into distribution center for North America.--Team member in multi-site ERP system switchover and integration. --Assisted with business unit consolidation from sites in Switzerland and Pennsylvania to Michigan, including logistics planning, inventory relocation and integration, and operations integration.

Managed a staff of 11-14 full time employees in a genotyping core facility. Responsible for colony genetic quality control data and breeding selection data for transgenic and knock-out mouse colonies in worlds largest mouse repository. Department performed > 1 million PCR assays/year. Designed architecture for data tracking and capture system and worked with IT for programming and successful roll-out.

Managed high-throughput genomics cloning group including proof of principle for cloning approach and throughput scale-up. Was hands-on with manufacturing design, writing SOPs, hiring and training of staff, and product launch. Designed architecture of LIMS system and oversaw automation integration. Worked with Product Manager for successful product launch.

Managed high-throughput genomic cloning department, including the cloning, expression testing, and manufacturing of expression ready full-length ORFs. Helped design LIMS system to drive automation and track clones through cloning and expression process.

Responsible for manufacturing, quality control, and inventory control of a full line of native and recombinant restriction enzymes.