Reporting to Director of R&D• Coordinate/track project deliverables for new product development with cross-functional leadership and functional teams – Mfg, R&D, Clinical Operations & Field, RA, , Med Affairs, QA• Ensure design control phase gates elements are completed from conception to launch• Provide technical oversight on project deliverables and ensure team is focused on critical priorities and understand critical path items to ensure timeliness of completion• Scope and develop schedules for new projects/products from conception to launch for FIH, EUMDR, and FDA PMA, communicate schedule risk with leadership

Reporting to Chief Operating Officer• Manager of multiple engineers and manufacturing manager responsible for all product builds, processing equipment and process validations• Assess and drive team deliverables to achieve effective and safe manufacturing environment.• Ensure all reportees drive for best manufacturing practices and have full project load• Work with finance, purchasing and receiving to ensure items are adequately reported and scheduled

• Lead of multiple engineers to manage process validations for all processes related to medical implant (over 90 processes)• Establish project scope, track execution, perform FAT, manage deadlines for process validations • Process expert for manufacturing issues, deviation assessment, SOP and Quality documentation updates, aid in inventory management, personnel training• Champion to integrate manufacturing operations to mature quality systems for common non-conformance and CAPA assessments, electronic document repository and batch records

• Responsible to transfer product line and operations from Japanese based company to the US• Write/execute validation protocols and reports; review equipment drawings and design• Purchase and design processing equipment and quality testing equipment • Develop and write all standard operating procedures for consistent processing

• Updated site P&IDs to match as-built status of equipment configuration by creating P&ID redlines after walkdown of equipment• Provided technical assessment of changes made to site P&IDs and evaluated the impact of the changes with respect to quality, validation, engineering design and cGMP compliance• Use quality system (Trackwise) to assess deviations and initiate change control for new equipment purchased for use in the facility• Updated preventative maintenance program and product changeover programs for multiple pieces of equipment

• Process engineering support of construction and start-up of new large scale manufacturing facility • Reviewed automation code for processing prior to performing commissioning activities to ensure that pressure holds, CIP, SIP and processing operations are correctly performed• Designed and executed shakedown/mixing studies of media preparation successfully• Created and reviewed SOPs and electronic batch records for media preparation area• Conceptually designed, reviewed drawings and implemented use of disposable equipment for process efficiency

Engineer I, MSAT (Manufacturing Science and Technology) Cell Culture Jan 2007 - May2008• Subject matter expert for inoculum train and production area for two product technical transfers from process development to large scale manufacturing facility• Worked in cross-functional teams for process/equipment changes for each new product• Provided 24hr scientific and technical support to large scale manufacturing floor • Conducted data analysis for process monitoring, optimization, and investigations; daily and weekly presentations of data to cross functional team • Worked on small-scale experiments; use JMP & design of experiments (DOE) for large-scale process and media optimization, cleaning validation, new technology validation and large scale satellites • Responsible for technical assessments and manufacturing document review (SOPs, validation documents) • Proficient in basic theories, principles, techniques, and operations CC processes and reactors • Training on LEAN manufacturing practices (Class A); DMAIC• Wrote VB code in Excel to manage process data which leads to enhanced investigational support• Developed operation/drug theory modules, presented & trained site (all groups) • Evaluated and implemented new technologies (Discoverant, SIMPCA, PI) for advanced data analysis, Designed additional PI user interface for extensive and straightforward historical data retrieval• Designed and created CC PI historian Process Book User Interface (manufacturing intelligence application) using VB code for real-time screen shot and process view of all vessels in manufacturing facilityAssociate Engineer, MSAT Technical Project Manager Jan 2006 - Jan2007• Lead & organize technical transfer meetings, manage project deadlines, follow up on action items• Maintained technical transfer weekly/monthly update presentations for upper management• Data/project support for key investigations for process validation necessary for FDA approval

• Designed and implemented evaluation model created in Microsoft Excel for RFP responses for a $45 million dollar spend category for large energy Supply Company• Confirmed baseline model to estimate projected savings • Using evaluation model, conducted in depth supplier resource distribution and forecast