Project Lead - Process Intensification Technology - converting existing cell culture fed batch process to continuous using perfusion technology.- Serve as owner's rep on a $140MM design/build upgrade (including new equipment specification, procurement and installation) from fed batch to continuous processing in an existing cGMP manufacturing facility using 3rd party designer and separate party general contractor.- Leading cross functional client team comprised of upstream, downstream process and automation engineers, quality, procurement, finance and scheduling professionals in scope, budget, schedule development, action items identification and execution.- Negotiated terms and conditions on behalf of client for $15MM of long lead capital equipment and $13MM professional design services (including Delta V); all equipment arrived on time to spec and installed without additional cost. Successfully enforced terms when technical/contractual issues arose.- Leading instrumentation and controls team in protocol development and start up execution across 54 new process system packages (fermentation, tangential flow diafiltration, ultrafiltration, chromatography) interfacing with Delta V. - Found alternative route to bring in four 15kL bioreactors to 3rd floor, sparing client from cutting a hole through the roof as recommended by the general contractor, saving over $300k in installation costs.

Project lead for a dual tech transfer of client's biosimilar product to a new U.S. CMO to satisfy patient demand. - Led joint CMO/Client cross functional team comprised of process engineers, quality, validation, procurement, shipping and finance professionals.- Completed scope and schedule for Phase I to ensure timely shipment of first commercial batches from its European site to its U.S. fill/finish site to ensure commercial availability. Delivered detailed schedule and used it to communicate with team to track weekly progress and report out to client leadership.- Successfully scheduled and executed activities for first commercial bulk drug substance batch to arrive on time to U.S. fill/finish operations.

Led a team of 20+ automation, instrumentation and controls engineers across the Software Development Lifecycle (requirements analysis, implementation, start up and qualification) of HVAC building automation (Siemens) plus 8 new process suites (Delta V v 4.3) consisting of Bulk Active Product, Buffer Prep & Hold, Column Packing, Chromatography, Micro/Ultrafiltration, Homogenization, Clean-In-Place, Sterile Supply (PLCs), Clean Steam and Water For Injection (PLCs) systems. Compressed change control process cycle times 30% through development of progress dashboards for each suite team to receive daily status of deliverables and schedules. Applied pivot tables (Excel) to analyze progress data per process suite. Reported on progress to senior Merck leadership using Microsoft PowerPoint and PMP tools including Earned v. Planned Value. All key project documentation were archived under version control in Sharepoint.

- Developed Net Present Value/Return On Investment model for preclinical projects either currently funded or in consideration of being funded by the Foundation. - Established Project Portfolio once valuations for each were in place to serve as baseline when assessing quarterly progress for each; provided a template to CEO of an executive quality business proposal suitable for use by scientific advisory board to structure new research projects to CMTRF Board.

Led team of 3 project managers and over 50 staff plus external contractors in the upgrade of CSL Behring's existing parenteral manufacturing operation plus its syringe packaging line. Program consisted of the following: 1) New RABS installation, including Delta V DCS 2) Syringe Filler Overhaul, including SCADA and HEPA System Upgrades, 3) Tech Transfer of two commercial products from one manufacturing area to another, and 4) Syringe Packaging Line (Pre and Post Seasonal) overhaul for Afluria flu vaccine.Developed budget (including statement of cash flows) for filling and packaging projects; presented to senior client leadership with both CSL and Seqirus for Seqirus' approval (CSL Kankakee is a contract manufacturing site for Seqirus). Developed scope, schedule (MS Project) and budget (MS Excel), including month-end financial report for presentation to Seqirus Steering Committee, reporting out using Microsoft PowerPoint application.Led contract negotiations with equipment vendors; performed vendor/contract management in ensuring the equipment and services were delivered on time, within budget to ensure timely equipment start up.Applied Earned v Planned Value as reporting tool across each project and overall program for both schedule and budget. Program completed on time and within budget. Recognized by client for technical and team leadership. All critical documentation was archived under version control in the client's Sharepoint application tool.

Led cross functional team of over 30 staff plus external contractors. Developed an integrated program schedule across four packaging lines that leveraged core team of packaging, controls and process engineers as well as members of clients Quality Assurance, SAP, Production, Maintenance, Procurement and Warehousing in concurrent overhaul (including serialization) of two existing packaging lines (one vial and one syringe) followed by 27 consecutive new product recipes that were programmed and qualified across the four packaging lines. The line overhaul was given a go-live date of February 22, 2019, which was achieved. In Q1-2019, the packaging department output achieved 200% actual v. planned. Led the core team meeting each morning; condensed the program schedule into a single page milestone schedule that tracked only critical path milestones; core team attendees were assigned critical path activities and reported on progress at each morning meeting. All four capital projects comprising the program were completed on-time and within budget. Deliverables included Project Schedule, Project Progress Reports (monthly to joint steering committee and weekly to global sponsors) using Planned v. Earned Value in the updates. Upon capital completion, developed a Strategic Plan that advised CSL on the resource needs of the packaging department (across three shifts) to ensure the 200% productivity gain is sustained.

Tech Transfer (Commercial): Led global cross functional client team across three sites in the transfer of secondary manufacturing ops for the first cell culture based flu vaccine, including changes to recipient site's existing fill & inspection ops. Prime challenge was the narrow window available to modify fill and inspection operations without compromise to existing commercial obligations. Met weekly with global team members from U.S. and Australian ops to design, install, validate and license new product for (contract) manufacture. Challenge was simultaneous overhaul of receiving site's existing fill and inspection equipment with adoption of new syringe and stopper presentation. Developed project charter, scope, schedule and $17MM budget. Delivered project scope on-time and 20% below budget. Enabled Seqirus to charge the bulk used in the qualification to the project. Designed and built custom portable filtration cart used to hold new disposable assembly in place and to transmit line pressure using in-line pressure sensor and PendoTECH data transmitter.Conversion of existing packaging line to accommodate new syringe and stopper presentation. Scope included scope, schedule and budget development. Developed user requirement specifications for new packaging equipment including. denester, accumulator, high-speed cartoner, check weigher, carton tracker, case packer and palletizer. Decision was made to limit existing line change to thermoformer to accommodate new presentation. Completed line change in advance of seasonal flu campaign, which commenced in May, 2019.

Project Lead in successful Tech Transfer of CSL's lead new product candidate CSL112 from pilot to commercial scale. Tech Transfer completion was under very narrow window to satisfy enrollment of 17,000 patient Ph.3 clinical trial program. Developed full project schedule (from Design thru Qualification), budget and process design, team leadership of over 30 client and contractor personnel in the process design, installation, start up and qualification of new commercial scale process. Deliverables included vendor contract negotiations and contract management. Start up consisted of the following campaigns: 1) Test Runs, 2) Engineering Runs and 3) Clinical Runs, leading to an on-time commercial readiness in advance of CSL112's Ph. 3 trial launch. Solved two separate process issues that each were potential show stoppers during engineering and clinical runs. In the first, I developed a model of the process using the pump curve driving the process. Superimposed over the pump curve were head pressures of the three return line scenarios, demonstrating the excess capacity of the pump. The model illustrated root cause of plugging to be due to non-Newtonian behavior of bulk suspension and would flow at lower pump pressure. In the second issue, my relationship with a major University enabled use of its expertise to prove my hypothesis that the root cause of second plugging was due to thermal loading of filter press membranes. The findings were applied to the CSL112 process. 60 contiguous runs were successfully completed in July, which satisfied 100% of Ph. 3 clinical trial material for the 17,000 patient program. Deliverables included Project Scope Document, Project Charter, Tech Transfer Document, Project Schedule, Risk Register & $20MM Budget. Presented to client's steering committee on progress, risks and budget. A weekly progress report was issued to core team leadership using Planned v. Earned Value. Documentation was archived in the client's Sharepoint application.

Wrote business plan, leveraging Porter's 5 Forces analysis, Net Present Value and Valuation for privately held Midwest company seeking private equity to expand operations in greater Chicagoland area. Presented with the client, the value proposition and plan to C-level members of prospective partner firms and their bankers. One of the companies identified in the business plan that would have interest in the offer has signed a letter of interest with the Client. Presently awaiting legislative approval from the state for changes to a law that allow local regulations to align with client offering.

Project Mgr. for $5MM Commissioning, Qualification and Validation of over 20 process mechanical systems as part of the restoration of an existing 300,000 s.f. biopharmaceutical manufacturing site to cGMP compliance in the manufacture of a new cell culture based biologic. Developed scope, schedule and budget. Developed crticial systems IOQ protocols and oversaw their execution.

Performed comprehensive assessment of site manufacturing and critical process systems in response to an event that potentially compromised integrity of finished product at the site. Identified over 70 process deficiencies, referenced regulatory guidance document(s) for each and included recommendations for improvement in the final report. Final report include P&IDs and statistical summarization of data gathered during the project.

By appointment of IIT President; Part of distinguished group of alumni dedicated to the global advancement of IIT and our fellow alumni. Presently, as part of the International committee, I am the responsible lead for development of the Global Gathering website, a conference to be held at IIT in 2014 that will bring distinguished alumni together to participate in a 3 day event sharing IIT's contributions to advancements in Water, Energy, Health, Security, Food and Innovation.

Led executive team consisting of CEO, CFO and Directors of IT, Regulatory, Supply Chain and Operations in determining whether to establish its own European operations after license agreement was severed by major European pharma partner. Developed and maintained project scope, schedule and budget. Met weekly with executive team to update schedule, identify issues, assign action items and track progress. Project scope included Strat Ops determination of new European headquarters (London) and expansion of Finance, Accounting and Materials Management modules (Epicor) to new site. Scope included commission testing of same. Provided commissioning services; developed and executed test scripts with client core team.

Responsibilies included new project execution, consultancy, business development and account management in the commercial biopharmaceutical industry sector. Opened western region with new biopharm clients. Duties included strategic planning, proposal development, contract negotiation, recruitment and retention of staff as well as leveraging experience in cGMPs, strategy, operations, finance, commissioning and project scheduling on client engagements. Secured $3MM in first time wins with Genentech (Vacaville, CA - process improvement to QC testing), Novartis Diagnostics (Emeryville, CA - CAPA investigation, remediation and closure) and Biomarin (Novato, CA - bulk manufacturing operational improvement). Secured first time proposals from Gilead (Foster City - QC process improvement) and Abbott (Abbott Park - QA process improvement).

2006-2012, part of distinguished group of alumni dedicated to advancement of the University of Illinois and its global alumni. As part of the Technology Committee, I was the responsible lead for development of the Strategic Plan that built the business case for adoption of technology applications that would improve UIAA's connection to its 600,000 living alumni and more effectively serve its initiatives in global advancement and advocacy at the state and federal government levels.

Served as the Industry Sponsor to the UIC ISPE Student Chapter 2003-2009. Facilitated monthly meetings, which included keynote speakers from the major pharmaceutical companies including Abbott, Baxter, Genentech and Lilly.

Biopharmaceutical Practice Leader responsible for new business development and project delivery in the Midwest and West Coast Regions. Using Porter's Five Forces, developed and executed strategic plan for newly formed Midwest/West Coast practice. Successfully negotiated global Master Service Agreements with several major biopharmaceutical companies. Actively engaged in projects through close out.

Practice Leader in new business development and project delivery with four regional business development managers (Los Angeles, Houston, San Francisco and Chicago) as direct reports. Using Porter's Five Forces model, formulated and executed strategic plan for U.S. and Worldwide pursuits (including China, Australia and South Africa). Increased business line west coast revenues from zero to $18MM annually (2004-2008). Penetrated Life Science business line into the institutional sector with wins at University of Florida, University of Chicago and University of Illinois. Developed stand-alone Commissioning service line with development of commissioning methodology based on ISPE Baseline Guide. Secured commissioning projects with Abraxis Bioscience, Akorn Pharmaceuticals and University of Illinois. Wrote all proposals for personal pursuits and simultaneously reviewed proposal submittals from regional business development managers.

Project Leader with direct responsibility for client deliverables in Project Management of SAP Implementations as well as corporate strategy. SAP Clients included Lilly (Production Planning and QM configuration), Monsanto (SAP cGMP validation testing of Production Planning, Materials Management and Warehouse Management), Searle (worked in development of strategic plan for launch of Celebrex), Coca Cola (Project Management and functional testing of Production Planning, Finance and Quality Management), Johnson & Johnson Cordis division (assessment of QM module), and (Canada based) MDS International (corporate strategy with CEO, CFO and COO to determine how to integrate new acquisitions and to identify potential new products and business sectors that could be expected from cross pollination of new assets).

6 years of progressive accountability from process engineer to Director of Critical Systems supervising staff of 4 supervisors, 35 hourly employees & departmental budget of $15MM. Dealt directly with FDA as lead engineering representative during intensive site audit that resulted in consent decree. Provided technical support for process systems in primary & secondary manufacturing as well as utilities operations. Designed process systems, specified, procured, installed & started up (commissioned) large scale capital equipment that were part of process design.

Designed Manufacturing Process Systems, specified, procured, installed and commissioned high speed packaging and automated storage and retrieval equipment; Managed staff of 30 mechanics in high speed packaging department; Responsible for development of preventive maintenance program for equipment across 16 lines within packaging department; Lead engineer for fully automated distribution center, implemented preventive maintenance program as well as provided troubleshooting & repair of 8 fully automated cranes storing finished goods for shipment.