Responsible for overseeing all of bluebirdbio's manufacturing and testing activities. Partner closely with Contract Manufacturing and Testing strategic partners to bring bluebird's three commercially-approved autologous gene therapies to create more bluebird days for our patients.

Responsible for Global Quality functions at bluebirdbio, including Compliance, Quality Systems, and building and maintaining Inspection Readiness for both bluebird and our many external partners.

Responsible for External Vector Manufacturing for entire blubird bio portfolio, including both genetic disorders and CAR-T products. Tasked with building team and capabilities to translate from clinical to commercial production.

As global leader of the Vaccine Technology and Engineering team for Takeda Vaccines Business Unit, responsible for world-wide technical support (process and analytics) of the global products in the late-stage global vaccines pipeline. In partnership with CMC team, responsible for strategic development and execution of Process Validation and delivery of Ph III supplies. Lead business and technical interactions between Takeda and a critical Contract Manufacturing partner and represent manufacturing on global brand team. In addition to supporting readiness for registration of Norovirus and Dengue vaccines, responsible to grow organization and create the infrastructure needed for successful commercialization and routine supply of these vaccine candidates to customers around the globe.

Lead an increasingly large group of engineers (currently ~85 full time employees and ~15 contract employees) in the technical support of live virus vaccine production. Initially responsible for the Rotateq production process, currently supporting the Measles, Mumps, Rubella, and Varicella-containing (chickenpox, shingles) products. Technical responsibilities for the group span from sterile component supply through bulk production, lyophilization and final product inspection and include direct floor technical support, regulatory support, validation, and automation. Key personal roles include leading team and broader Tech Services organization through significant reorganization efforts, refinement or creation of business processes to support the new organization, and leading efforts to eliminate less value added work to allow engineers to focus on higher value add activities.

As Technical Operations Lead for the Rotateq bulk manufacturing facility, lead group of up to 13 engineers responsible for all technical support, troubleshooting, and process improvements for the rotavirus bulk manufacturing facility. Oversaw or approved all technical activities, including Change Control, Deviations, Sterility Investigations, Corrective and Preventative Actions, Site Master File / Master Batch Record management, regulatory submission authoring, and regulatory audits. At the time of joining the group, the facility was operating at <10 MM dose/year production rate and a hypothetical highest output rate of 16 MM doses/year. Based on training in Merck Production Systems approaches, worked with operations partners to lead an increase to 27 MM in 4Q2011 with minimal capital investment. To support these tasks, built the technology team from 4 to 11 members over ~1 year. In subsequent role as Director and Technical Product Lead, increased scope to include strategic development and ongoing technical implementation of a series of significant projects across the Value Chain, including: a $50MM bulk facility expansion to increase compliance, supply robustness, and capacity; an improved thermostable formulation; and a smaller primary package supporting a 4x reduction in product cold chain. Developed an inventory modeling tool to project regulatory and status of changes to ensure supply continuity. Deployed an enhanced portfolio management process for resource planning and management. Created a roadmap for Emerging Market Tech Transfers for Merck vaccine products.

As team leader and then Group Leader, responsible for overseeing multiple solid dosage pharm products through development, scale-up, and commercial launch. This includes both directly leading programs as well as coaching direct reports leading their own programs while managing up to five engineers. Across these programs, lead the technical team in multiple technical transfers, production of unprecedented Ph III and Ph V supply needs, authoring of the applicable pharm commercial filing sections, and commercial validation. Served on the Integrated Development and Supply Team (IDST) as Technology seat and as process lead in world-wide stability investigation critical path to product launch. Teams were recognized for rapid successful development of new technologies to Merck, namely bilayer compression and precision pan coating, including leading the team that received the first Corporate Merck Sigma award given for Design for Six Sigma.

Responsible for leading technical teams in the process optimization and scale-up of oral dosage pharmaceutical products and the creation of pivotal clinical material. Collaborated with Formulation Development teams in the definition of product formulation and processes (typically ~1kg lab/pilot plant scale) and subsequently lead process optimization at the 1/10th (biobatch) scale. Lead development of multiple pharm processes, including high shear wet granulation, roller compaction, extrusion / spheronization, encapsulation, single layer compression, and bilayer compression, a novel technology to Merck. Externally presented on pharm process development at forums including PQRI, AAPS, and AIChE. Held increasing levels of responsibility culminating in managing four direct reports and leading teams of up to ten engineers.