- Accountable for CMC activities executed throughout our CMO network, including Cas9, sgRNA, viral vector, Drug Substance and Drug Product manufacturing.

- Responsible for oversight and management of Drug Product manufacturing activities for 3 allogeneic CAR-T programs.- Responsible for implementation of manufacturing and analytical CMC improvements to enable clinical development and advancement.- Successfully onboarded 2 additional manufacturing sites and oversaw Technical Transfers and IND enabling operations for 2 additional allogeneic CAR-T programs.

• Accountable for developing initial Facilities and Engineering function capabilities to support both Gene Therapy and Gene Editing platforms for early development, clinical development, and commercialization manufacturing.• Partnered with Process Development to develop plasmid manufacturing process and responsible for capital project to enable manufacturing capabilities.• Planned, coordinated, and executed demonstration run to establish proof of concept to manufacture platform AAV process in a commercial scale single use bioreactor.• Performed quality audits and technical evaluation associated with the selection of key CMO suppliers.• Provided manufacturing representation for CMC programs as required.• Responsible for technical support of internal clinical manufacturing operations as well as preliminary site selection and design concepts to enable future internal commercial manufacturing capacity.

• Accountable for managing Drug Substance and Drug Product operations, contracts and relationship management at Contract Manufacturing Organizations (CMOs).• Negotiated multiple clinical and commercial Manufacturing Supply Agreements (MSAs), and PPQ execution Statements of Work (SOWs) to enable supply with CMO partners.• Supported long range capacity planning analysis with Supply Chain partners to identify and execute capacity expansion projects to ensure Drug Substance supply.• Managed partnership with Biogen to close out Transitional Service Agreements (TSAs) for all Biogen Technical Operations services provided to Bioverativ through the transition spin-off period of 2 years.• Delivered on CMC goals through oversight of CMOs for tech transfers, Process Performance Qualification (PPQ) campaigns, clinical and commercial manufacturing activities, including the execution of 3 PPQ campaigns across multiple CMOs.• Responsible for $250M annual spend for commercial and clinical Drug Substance manufacturing, capacity enabling technical transfers and PPQ campaigns.• Executed $170M purchase of product inventory from Biogen at the completion of the spin off’s final phase.

• Planned and executed Facilities & Engineering integration activities associated with the Shire / Baxalta merger and supported integration deliverables for the first 90 days post-close until the combined organization was established.• Shire Engineering lead for $450M Ireland strategic supply expansion capital project. Developed project requirement brief and led successful completion of concept and basis of design phases of the project.• Developed hiring plan for expansion project execution from concept phase through operational startup.• Established engineering design, CQV strategy for delivery of the expansion project.• Developed and led engineering team responsible for the project execution.

• Responsible for hiring, developing and managing the Process Engineering function (30 engineers) for operational and engineering program support across all internal manufacturing operation sites, tech transfers and projects. • Facilities and Engineering member for the Site Leadership Team (SLT) for manufacturing operations.• Functional lead for study that evaluated manufacturing capabilities and identified strategic initiatives to achieve the manufacturing long range plan (LRP) and reduce risk. • Evaluated Contract Manufacturing Organizations (CMOs) capabilities to meet strategic supply needs. Assessment included capital investment required, timelines, and historical performance.• Led cross-functional regulatory observation remediation team to develop a new business process and system for single use equipment. Team met all regulator commitments on time and budget.• Engineering lead on project to define a global manufacturing control strategy including the integration of the QbD program into equipment design, control and alarm configuration.

• Responsible for managing a team of 8 engineers for the support of upstream commercial and clinical manufacturing operations at 3 biopharmaceutical facilities utilizing single use bioreactor and cell separation technologies, stainless steel bioreactors, and roller bottle technologies.

• Managed a team of 8 engineers for the support of downstream commercial and clinical manufacturing operations at 3 biopharmaceutical facilities, resolving issues such as chromatography flow control reliability, single use tubing degradation, column packing reliability, UF skid modifications among others.• Responsible for internal engineering resources to deliver equipment modifications and new chromatography methods for 2 commercial technology transfers to enable successful process validation run (PVR) campaigns and 1 clinical technology transfer• Responsible for internal engineering resources to deliver engineered solutions for downstream capital projects including the purchase of new chromatography columns and large scale chromatography skids.• Core member of team of three managers tasked with transforming and expanding the organization from a site based engineering organization to a functionally grouped organization across multiple sites (i.e. upstream, downstream, automation, etc.).• ETS site leadership member for 1 manufacturing site and contributing in setting site goals, priorities, and capital project portfolio management.

• Facilitated engineering resourcing for site process engineering support for manufacturing operations and capital project design and implementation for a commercial multi-product biopharmaceutical facility. Areas supported included roller bottle, bioreactor, purification, media and buffer suites.• Coordinate cross-functionally with Manufacturing, Facilities, QA, Validation, and other functional groups as required to develop system requirements and recommend improvements.• Key team member in the development of a new prioritization and resourcing process to maximize the performance of project teams supporting manufacturing.• Project manager for Clean-in-Place skid debottlenecking sub-team project to improve purification facility output. Success of overall project resulted in team being awarded the CEO award in 2009.

• Member of a new core team responsible for building business systems to support Operational Excellence (OE) idea generation, execution, measurement, and culture shift. Lead team responsible for developing strategies to measuring improvements accomplished through OE projects. Initiatives included implementation of resource tracking tool, performance board enhancements and developing a site vision for a grassroots OE effort.

• Experience included role as the team lead for 8 large and small scale chromatography skids in 3 separate production suites including responsibilities for managing two engineers on the team• Purification process equipment owner for a multi-host / multi-product, biopharmaceutical manufacturing facility. Systems owned include UF/DF, viral filtration, vessels, chromatography skids, and bulk fill• Primary responsibilities included ensuring equipment is properly maintained, performing root cause investigations for manufacturing deviations, implementing corrective actions, providing on-call support for manufacturing operations, and providing technical support during regulatory inspections• Supported the successful introduction of two new products and their conformance campaigns in two separate purification suites• Represented the end user in review and approval of specifications, requirements and design, commissioning, and qualification documents for the installation of a new chromatography skid

• Cell culture system owner lead providing consistent improvements and direction across the seed, perfusion, and production bioreactor operations• Performed root cause investigations for bioreactor contaminations, and coordinated maintenance activities under tight timelines after contamination events to return the equipment to manufacturing