Manage Operations staff of 70 in the production of proprietary gene therapy products. This includes manufacturing, facilities/engineering/validation, manufacturing science and technology (MSAT), and supply chain, operations at the Lexington, MA site, as well as managing the GLP facility and supply chain operations at the Amsterdam, NL facility.Team responsibilities include:o Manufacturing: Production of early and late-stage clinical supply, commercial readiness, and process and operator qualifications.o Supply Chain: Vendor and material management, MRP implementation, external vendor/CMO management, and redundant storage sites for critical raw materials (cell and virus banks).o MSAT: Establish processes and procedures for, data analysis and trending to meet compliance requirements, new product introduction, trouble shoot technical MFG issues/deviations, and to manage internal and external tech transfers. o Facilities and Engineering: Equipment and process validation, calibration, facility and equipment maintenance, and multiple expansion projects in Amsterdam and Lexington facilities (R&D and PD Labs, Pilot Plant, and scale-up capacity).o Create an environment to enable experienced and highly motivated teams to be successful. Foster: teamwork and team chemistry, empowerment/ownership, cross-site harmonization, measurable goals, and clear roles and responsibilities.o Performance of detailed in-process data led to 2-fold yield increase in yield and improved process consistency for lead HemB process.Cross functional responsibilities include:o cGMP compliance, management and resolution of deviations, CAPA, and corrective actions, content and review of regulatory filings, commercial readiness preparation, short term demand modeling/projections, long term capacity planning, employee growth and advancement planning, and development/management of departmental budgets to meet corporate objectives.

Headed up Manufacturing and Supply Chain staff of 30 in the production of early and late-phase anti-cancer clinical products. This included the internal production of the company’s proprietary whole-cell products, as well as managing external production of small-molecule products.• Directed start-up and operation of new aseptic manufacturing facility.• Led manufacturing staff of 20 in cell culture, harvest, formulation, and filling of company’s Phase I, II, and III mammalian whole-cell HyperAcute anti-cancer products.• Restructured manufacturing organization to clarify roles and responsibilities resulting in higher employee retention and a 50% reduction in time required for new-employee training and qualification.• Created and staffed process development team. This team successfully developed, MFG processes of new cell lines, evaluated new potential production platforms, decreased run-to-run variability, and increased the yield fourfold for one cell line, and 25% for the second cell line.• Developed and implemented Tech Ops function to ensure effectiveness of SOPs and increase cGMP compliance in training, deviation investigations, and change-control resolution.• Built product demand models to optimize production planning and ensure fulfillment of clinical demands for whole-cell and small-molecule anti-cancer therapies.• Spearheaded 5X scale-up of the small-molecule API and DP manufacturing processes, enabling the company to supply and plan its pivotal Phase III trial for its lead indication.• Implemented level-loaded JIT shipments from vendors to overcome space constraints while ensuring raw-material availability. • Implemented ERP (QAD) for supply chain, purchasing, quality, and MFG in validated state. • Drove cost savings through price negotiation and supply agreements, resulting in 50% goods cost reduction for HyperAcute platform.

Provided manufacturing and facility start-up expertise for three projects.

Led manufacturing operations staff of 35 in production of Phase III mammalian whole cell anti-cancer product. Worked cross-functionally to ensure achievement of production, regulatory compliance, quality assurance, and FDA Pre-ApprovaI Inspection (PAI) goals.• Directed mammalian cell culture production, harvest, formulation, filling, and technical operations functional areas to ensure achievement of production and compliance goals.• Served as manufacturing representative on cross-functional team responsible for scaling up 50L clinical process to 500L commercial launch process.• Reorganized and developed operations staff to create high-functioning team by building reporting structure to take advantage of individual’s strengths and ensuring clarity and alignment of roles with corporate objectives.

Defined functional and operational upstream requirements for new 2K to 12K clinical/commercial manufacturing facility. Functional areas included inoculum scale-up, cell culture production and harvest, as well as media prep, parts prep, and cell banking. Worked with associated functions to ensure all facility and equipment validation protocols were executed and the acceptance criteria were met. Led upstream effort in the preparation, and successful completion of FDA pre-approval inspection (PAI).• Worked with contract engineering firm CRB to ensure the design of the upstream equipment (bioreactors, in-line centrifuges, media prep vessels, and transfer panels) met operational requirements.• Designed robust sterilization, production, and clean in place processes to ensure product quality and sterility.• Reviewed and approved commissioning and validation (IQ, OQ, and PQ) protocols• Served as the lead cell culture manufacturing representative on a multifunctional teams responsible for: tech transfer, writing and approving process validation protocols and summary reports, and generation of the BLA for submission to the FDA.• Hired and led a cell culture manufacturing team of 26 that maintained a 97% success rate from start-up through PAI. This included production of the conformance batches for commercial launch.• Assisted process development in the construction and start-up of a 50L bioreactor pilot plant designed to enable a seamless tech transfer from development scale to clinical production.

Headed up a tech transfer team responsible for transferring a microbial manufacturing process from Alameda, California to a CMO in Kundl, Austria for phase I production. Worked cross-functionally to ensure all production, QA, QC, regulatory affairs, material management, and timeline objectives were met.• Person in the plant for tech transfer into CMO pilot plant and then into clinical production facility.• Worked cross-culturally to coordinate meetings and information flow to meet project objectives.• Assisted in additional tech transfer of mammalian cell production process from Baxter’s Orth, Austria facility to new manufacturing facility in Neuchatel, Switzerland. Used interpersonal skills to provide process knowledge and facility start-up experience to facilitate the transfer process.

Led cell culture staff of 8 in the start-up and licensure of new manufacturing suite. Trained staff in upstream operations and cGMP compliance.• Executed validation procedure (IQ, OQ, and PQ) for the new manufacturing equipment.• Worked with validation staff to redesign the SIP validation philosophy to align with intended operational use.• Hired and trained additional staff to meet production goals.• Functioned as the cell culture manufacturing representative on tech transfer team to incorporate new manufacturing process from Orth, Austria.