Program leadership and oversight of portfolio of pre-clinical assets including strategic planning and prioritization; Defined development pathway of required deliverables & decisions, resource models, budgets, and governance process for novel therapeutics from lead selection through regulatory submissions and Phase 1 testing for both internal and partnered assets; Established and facilitated long range planning process to enable corporate strategy development and translation of mission to goals to objectives through scenario option planning models for potential new projects and evaluation of current programs; Established project management and CMC leadership functions and creation of best practices and standardized tools; Led nascent build of multiple operations functions during early start up of company including HR, Business Operations, IT, Finance, and Facilities

Lead technology development and innovation for cell therapy manufacturing and testing. Manage technology development strategy and road map. Oversee collaborations with academic and industrial partners. Perform due diligence activities for Tech Ops organization.

Program and project management support for next generation manufacturing development project.Facilitation of novel technology corporate governance committee.Strategic and tactical guidance for novel technology projects from initiation through implementation.

Lead cross-functional team in development and commercialization of cell-therapy program. Managing timelines, risk identification/mitigation, problem solving, and delivering on opportunities for continuous improvement.Strategic planning of manufacturing of critical raw materials and leading engagements with contract manufacturing organizations.

Program owner for cross-functional global business process for technology transfers of manufacturing processes between 8 global facilities including internal and contract manufacturing organizations.Defined and developed strategic direction for product commercialization corporate and site based activitiesProvided tactical support for an average of 15 technology transfer projects per year from scope and budget definition through execution and product launch. Developed and lead continuous improvement projects from business case development through senior management review and approval to optimize speed, efficiency and success of technology transfers and product commercializations.Identified and drove change management initiatives to ensure alignment with current best practices, strategic focus, and regulatory requirements.

Performed analysis of new technologies to make recommendations on potential investments. Conducted product concept evaluations for pharmaceutical unit operations.Liaised with vendors and internal client groups to facilitate project completion.

Developed freeze-dried protein therapeutic formulations and manufacturing cycles.Designed experiments to deliver required data to make well informed product impacting decisions.Qualified equipment in a newly installed lab.