Responsible for process design review of capital projects in excess of $1M including adherence to corporate standards and quality requirements. Developed a process for evaluation of the status of projects to determine acceptability for funding and projects progressing through the next phase of design or construction.Process lead for the design of a new manufacturing facility for the production of second generation products. This project involved introduction of new technology for continuous cell culture through capture chromatography. Responsible for working with the engineering firm for the design of the new facility along with translating development data into facility design requirements. Process equipment involves single use components for media and buffer prep and hold, process intermediates, and bioreactor operations. Engineering lead for a feasibility study for a new development platform for gene therapy using viral vectors. Responsible for working with an engineering firm to establish space and building requirements and budgetary estimate for Phase I/II development area along with a Phase III and market launch facility. In addition to the manufacturing spaces, the project included areas for QC lab, additional development lab, and a vial filling suite along with the required utility infrastructure.Acted as the Biologics division subject matter expert (SME) for upstream and downstream process related issues. Activities included writing company standards for process equipment.Responsible for facility fit analysis for several new processes to establish budgetary impact of implementation.Provided technical leadership for the development of a new process for frozen storage of formulated drug substance and shipment to drug product sites. Project involved development of drug substance bag filling system.

Provided process engineering support for facility modifications and design of facility upgrades.Provided engineering support for the design of the fourth process train including design and procurement of the process equipment required to complete the clarification and capture chromatography operations for the second processing suite, along with design and installation of a new chromatography column packing and qualification area.Lead engineer for the design and construction of a downstream purification facility. Responsible for working with the engineering firm for design of a new facility along with management of internal process engineers for the procurement of all purification process equipment. Process equipment included ultrafiltration system, chromatography skids, CIP system, chemical delivery systems, and SUT buffer storage totes and process mixing totes.

Lead engineer for the design, specification, procurement, construction, and commissioning of a manufacturing facility in Framingham, MA. Project involved the retrofit of an existing warehouse facility into a perfusion cell culture manufacturing facility. Responsible for the design specification, procurement, construction, and FAT of all process and clean utility equipment. Project evolved from a simple manual process to a fully integrated DCS controlled process facility including MES implementation. Project included cell culture for up to 2K liter perfusion bioreactors, media and buffer preparation, and initial clarification and capture chromatography operations along with clean utilities including RO/DI, WFI, clean steam, and CIP systems. Managed a team of in-house engineers for the process and clean utilities along with working with an outside engineering firm. Provided engineering support for changes following the facility construction along with engineering support for the commissioning effort for the facility.Provided process engineering support and review for the design of a new facility in Lyon, France. Project included the design and construction of a purification facility including buffer preparation, chromatography, filtration, and centrifugation operations in an open processing format. Provided design input to the Genzyme team located in France along with interactions with the outside engineering firm for the conceptual and preliminary design phases of the project.Responsible for the development of a staff of engineers with a focus on process equipment design and engineering.

Responsible for the feasibility analysis, conceptual study, and cost estimation to retrofit a facility to support the manufacturing of a new product and introduce a perfusion process. Project included facility review for reuse of process equip., util. survey, cost estimation for new equip. and facility mods, and presentation for capital approval. After approval, acted as Lead Engineer responsible for the coordination of in-house resources and contract engineering firm resources for the design, specification, and procurement of proc. equip., P&ID development, detailed piping layout review and construction oversight.Lead Engineer for the design, specification, procurement, construction, and commissioning of a 180,000 sf manufacturing facility in Belgium. Feasibility and conceptual design was based on a site in the US. Project changed to the retrofit of an existing facility in Belgium for the introduction of large scale monoclonal antibody production capabilities including media/buffer prep., cell culture (10K biorxs), centrifuge clarification, and several chrom and filtration steps, developed CIP/SIP strategy for all process equip. and piping and performed utilities analysis for critical process utilities including hydraulic modeling of process water systems (RO and WFI). During prelim. and detailed design, routine travel to engineering firm's facility was required to monitor progress on piping design, equip. procurement, and the development of piping specs. During construction, conducted facility walkdowns to monitor const. progress and ensure conformance with design specs. After construction completion, provided on-site support for punchlist walkdowns, commissioning, start-up, and troubleshooting of the facility. Project required coordination of all internal engineering disciplines as well as close coordination with Mfg., Dev., QA, and Val. depts.Responsible for the development of a staff of engineers with a focus on process equipment design and engineering.

Lead Process Engineer for the design and specification of expansion project for the Allston manufacturing facility including the design, specification, and procurement of process equipment (i.e. process vessels and perfusion bioreactors). The process design was conducted in-house with the piping design and construction outsourced. Responsibilities included the process design and detailed review of eng. firm's piping design. Conducted frequent construction walkdowns to ensure compliance with design. Provided oversight of the construction and start-up assistance. The project was completed with a very tight timeline with successful bioreactor runs from the first engineering run.Lead engineer for the design of a $330M manufacturing facility from conceptual design through basic engineering and equipment and piping specification. Facility was designed for monoclonal antibody production including media prep, cell culture, centrifuge clarification, several chrom and filtration steps and final formulation. Project included a completely separate perfusion process including similar process steps to those described above for enzyme production process.Provided technical review of engineering firm design and construction firm installation for several projects including animal research facilities and lab facilities.Responsible for the design of several expansion projects for various processes including feasibility studies, layout design, P&ID development, project estimating, specification and procurement of process and utility equipment, installation coordination, documentation coordination for validation, and start-up and commissioning.Site engineer responsible for Allston 130,000 sf manufacturing facility including perfusion cell culture, purification, and fill and finish capabilities. Responsibilities included design and procurement of vessels and mods to media area, cell culture (i.e. bioreactors), and purification equipment (i.e. filtration and chrom systems).

Responsible for Installation Qualification for chilled water system, cooling tower system, HVAC systems, RO water systems, clean steam systems, seed bioreactor system, and media preparation systems.Responsible for Installation Qualification and Operational Qualification for Fill and Finish equipment including an autoclave, a depyrogenation oven, a vial filling machine, a lyophilizer, a capping machine, and a labeling machine.Responsible for writing and executing the Performance Qualification for the Fill and Finish autoclave, depyrogenation oven, and the HVAC system.Involved in the adjusting and rebalancing of the Fill/Finish area HVAC system.Responsible for the documentation and qualification of the Landis and Gyr BMS control system.

Responsible for writing and revising Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols and reports. Resposible for qualification activities for dry heat ovens, autoclaves, glasswashers, cryostorage units, and purified water system. Responsible for routine metrology program.

Responsible for debugging and programming control system for CIP/SIP system. Responsible for validation of the CIP and SIP systems. Responsible for maintaining PLC software documentstion for CIP operation. Responsible for manufacturing product following SOPs. The process included centrifuge clarification, filtration separation, buffer preparation, and liquid chromatography.