Madison, Wisconsin, United States
Project Management Professional with more than 15 years experience in the biotechnology and pharmaceutical industry. Experienced in project planning, execution and control for FDA clean room and biosafety level containment facilities, regulatory compliance, and new product development. Skilled in leading diverse cross functional teams. Built a positive culture by developing people and strong teams to deliver results.
Ensure global operational initiatives align with strategic priorities by standardizing processes, establishing effective governance, and driving cross-regional alignment to enable consistent hih-impact project execution.
Deliver key strategic objectives to support continued growth and innovation in the Brands Quality & Operations organization. • Directed Brands Quality & Operations PMO by supporting the Quality & Operations Leadership team with the strategic portfolios, by ensuring priorities were clearly set up, aligning on progress & key decisions, and coordinating active operational launches. This resulted in advancement of products from pipeline to commercial launch. • Lead the Operations Readiness Review (ORR) as part of the bi-monthly meeting with the Extended Quality & Operations team (EQOLT) to communicate status, and review priorities based on status of all programs. • Collaborated and communicated effectively with various launch teams in order to provide clear direction and appropriate support/coaching.
Full accountability for facilitating and managing cross-functional execution of Stratatech Programs for major growth and critical lifecycle initiatives. • Developed the Operational Launch Plan by defining and prioritizing multiple projects, resulting in an aligned, efficient sub team structure with the ability to meet timelines. Important milestones included facility and equipment qualification, manufacturing performance process qualification (PPQ), biologics license application (BLA) filing, FDA pre-approval inspection (PAI), and Commercial Launch. • Established internal packaging and labeling processes for new products by determining need, assembling cross-functional teams, and developing tools to facilitate the processes. • Fostered team agility by directing attention to the near-term goals, describing the “must haves”, and visualizing the possible outcomes. This enabled the team to pivot to a new solution quickly, and maintain a positive team environment. • Launched company communication plan by development of meeting norms, elimination of non-value activities, and providing a forum for neglected topics, that resulted in focused, purpose-driven meetings and efficient use of resources.
Program management leadership for one or multiple early and later-stage therapeutic development programs, from pre-nomination planning through IND-enabling studies and clinical development. • Collaborate closely with the clinical team, senior management, project leaders, and partners to develop and maintain integrated project plans/timelines for the clinical team including key commitments, deliverables, resources, and thereby ensuring projects are moving effectively toward their milestones and company goals. • Apply project management best practices, including coordination and participation in project team meetings, development of meeting agendas, program timelines and budgets, streamlined and efficient meeting management, distribution of meeting summaries, and efficient follow up of all relevant action items. • Assist in the identification and timely resolution of project issues – including those related to timing, resources and funding, to prevent delays in project milestones • Interact effectively with teams cross-functionally to integrate project timelines into a unified project/company timeline • Track progress against project plans, generate regular status updates, and communicate progress and issues to management
Managed multiple projects for new product development. Lead virtual and co-located teams of 30+ individuals, with budgets up to $30MM.