Jackie Warren Email and Phone Number

•Key individual in the development of the new Product Development Process (PDP) using a stage – gate methodology, currently implemented at multiple sites •Implement streamlined documentation for greater efficiency in the new PDP •Provide training on the PDP process to team members as well as R&D and Marketing •Provide Project Management and Technical Transfer support for new products from idea to commercialization•Contribute to on-site projects as well as cross-site projects with various levels of complexity and revenue expectations•Interact with R&D, Marketing, Business Development, Sourcing, Legal and Quality/Regulatoryduring the idea through the development phase of new products•Review and provide input to supply agreements•Support in-house developed projects with validation studies when applicable•Support OEM, and contract manufacturing projects•Coordinate with Purchasing, Planning, Operations and Distribution during the release to manufacturing to new product launch•Create documentation for Operations, Supply Chain and Quality departments•Select and design packaging and master labels for new products•Create and input all of the necessary item master, bill of materials, routings in the Oracle ERP system•Post-launch product support, such as documentation or design change •Offer technical transfer training to other team members•Assist ERP data integrity projects •Lead and evaluate the performance of staff within the technical transfer group

•Lead and evaluated the performance of a departmental staff of up to seven in the manufacturing and quality control testing of the Luminex based platform technology Beadlyte® •Managed all manufacturing aspects including the review of Quality control data and batch records for accuracy prior to inventory release•Technically trained new manufacturing personnel on Beadlyte® protocols and procedures•Assigned projects and managed appropriate timelines for personnel including custom Bead-link™ projects in a timely manner•Developed and implemented streamlined processes for greater efficiency and cost effective manufacturing •Troubleshoot product failures and/or initiate reengineering projects to make product improvements •Reviewed and monitored departmental purchasing requisitions •Responsible for departmental SOP/GOP training files for the Multiplex department•Provided scientific support to customers, technical support and sales personnel•Completed manufacturing jobs in the ERP systems (SAP and Oracle) by picking all of the raw materials and transacting the change between work centers•Key individual in the technical transfer of the Upstate Beadlyte® product line from Temecula, CA to Linco Research in St. Charles, MO

•Project leader in the development and the technical transfer of the Methylation product line from design to product launch•Wrote all documentation required for developed product•Product development support in the Amplifluor® Real-time PCR product line•Supervised product development including custom product development•Conducted employee performance and salary reviews•Technically trained sales, manufacturing and quality control personnel•Provided technical support in Methylation Specific PCR (MSP) inquiries•Responsible for departmental SOP/GOP training files•Key individual in technical transfer of the entire Beadlyte® product line from Upstate-Serologicals in Lake Placid, NY to Temecula, CA

•Cloned and purified recombinant proteins•Constructed plasmids for use in making Transgenic Mice for Genome Biosciences•Responsible for all custom product development for the department •Supported the Marketing department in literature review and editing•Supported technical service in customer complaints including direct communications with customers•Wrote and presented scientific posters•Participated in the technical product integration of the real-time PCR technology (Amplifluor®) and Methylation Specific PCR (MSP) from the Intergen-Serologicals facility in Gaithersburg, MD to Temecula, CA •Key individual in the product integration of the vector based RNAi GenEclipse™ product line

•Project leader in Molecular product development from design to product launch •Followed FDA and ISO regulations in the development of analyte specific reagent (ASR) products •Technically supported lab associates in their development projects•Provided technical training to various departments ensuring a successful transfer of R&D developed products to manufacturing •Collaborated with customers in the evaluation of new products•Wrote and reviewed all GMP documentation for manufacturing and quality control and other related documentation•Designed and created package inserts, product labeling and packaging

•Product and assay development from feasibility to completion•Trained new employees in DNA synthesis and purification methods and other required laboratory techniques •Wrote GMP documentation for manufacturing and quality control, including manufacturing procedures, raw material quality specifications, finished product quality specifications and product inserts. •Assisted in the development of PCR-based EIAs for infectious diseases, OligoDetect®, from feasibility to completion•Assumed the responsibility for the maintenance and use of DNA synthesis and purification instrumentation•Responsible for laboratory supplies and GMP/GLP equipment maintenance •Assisted in the development of molecular based EIAs for infectious diseases, Amplicon Detection Assay™•Assisted in GMP documentation •Optimized PCR and assay conditions•Stability studies