Drove requirements and alignment for a digital transformation, including data migrations and AI with digital pathology. Key point of contact for development and pharmaceutical partners on companion diagnostic (CDx) programs through the BioPharma business vertical. Negotiated contracts and additional terms to pull in milestones and recognize revenue.•Alliance Manager for crucial technology and roadmap partnerships, including pharmaceutical, University, research, and platform collaborations. Managed a portfolio and worked across teams to land multiple studies with BioPharma partners.•Managed key, Phase 2, and Phase 3 clinical trials in alignment with the company product roadmap from startup to closure.•Developed a lab-sustaining operations system and governance to ensure universal reporting in operations across all sites and business units within the organization.•Program manager for critical LDT and IVD tests. Built global regulatory strategies with prioritization to focus efforts.•Leader of divestment and consolidation efforts within the organization in alignment with the corporate strategy.

Inherited and remediated multiple government contracts and grants with options totalling over $220M. Improved relationships with our department of defense partners and successfully closed out 4 programs. Developed a program timeline for novel technology with a partnership proposal to take the product through clinical trials and into commercialization.Portfolio owner of various product lines for maintenance and product development, including pathogen reduction technology (PRT), freeze-dried plasma (FDP), whole blood core, and whole blood automation. Responsible for long-range plans, including annual budgets and 10-year PnL, and prioritization of projects through global commercialization and regulatory planning.•Inherited and remediated a portfolio of government contracts and grants.•Detailed product roadmaps aligned with corporate strategy, including sustaining engineering and consolidating products.•Worked through complex financial analysis of new products through ideation, manufacturing, and PMA readiness.

Global program leader responsible for driving a transformation in culture and operations in conjunction with McKinsey and Company. This included leading specific work streams associated with operations transformation, procurement, and change management. Prioritized and accelerated projects through review of impact while balancing employee communication and morale. Ensured initiatives tied to P&L impacts for the entire company. Worked with McKinsey and Company on translating a diagnostic into a strategic implementation plan to span over 3 years. Short-term results amounting to millions in savings and efficiencies in operations.

Responsible for bringing up an international medical device and pharmaceutical manufacturing factory through portfolio management and execution. Also, a key contributor to building an operations PMO. Portfolio leader for key operations projects in Vietnam and interactions across global sites. • Managed international teams for various projects, with members from Japan, India, Ireland, Vietnam, the US, and various other countries in Europe. • Managed international programs on commercializing medical devices and pharmaceutical products concurrently while setting up infrastructure and systems to support a plant built in Vietnam. Coordinated global commercial and regulatory acceptance of products and developed the critical path of the factory to support the strategic plan through 2021• Helped build a project management methodology and office within the operations group. Built the SharePoint infrastructure and process flow to instill project management methodologies universally and coached members of the organization on effective portfolio management and project governance• Developed an international project portfolio and developed prioritization processes between PMOs within the organization to support manufacturing capacity. • Key communication contact between functional groups, executive management, and stakeholders in developing and meeting annual long-term goals and ensuring ramp-up of the Vietnam facility through 2021 • Facilitated agile retrospectives/lessons learned to utilize best practices and knowledge within the organization and was responsible for creating a database with the ability for associates to interact globallyOther activities and projects include product development, process development and validation, EtO and steam sterilization validations, logistics, capacity planning, and vendor management.

Consultant for medical device industry; project management, manufacturing, and device trends

Managed cross-functional teams in the development and commercialization of medical devices and software in a variety of areasSupported business development via requirements gathering, proposal estimating and development, customer contact, and project sales

Managed international product and program portfolios while working with executive management and teams on annual operations plans and alignment for strategic direction, business philosophies, preferred practices, and guiding principles in a regulated environmentProvide leadership and guidance to specific cross-functional teams to develop and execute plans for commercialization of new productsWorked through the product development process from assessment and concept through commercializationDeveloped and managed complex timelines with large international teams sometimes with over 80 membersAnalyzed current manufacturing processes and worked through process improvement initiatives with quality, operations, and regulatory to increase throughput and yields on multiple productsPresented business cases and options to executive management to clarify product and program direction in alignment with company goals using industry trends, statistics, and analytical models

Evaluated and implemented process changes revolving around operations and qualityTook a large role in building a complex and robust quoting system to support quicker quote times and capture all relevant costs while giving future traceabilityManaged complex device programs and served as the cross-functional team leader and key customer contactWas responsible for the design, implementation, and production of the first proprietary product for the organization which included all phases from concept through launchEvaluated global trends and technologies and built a business plan to expand the organizations capabilities

Managed cross-functional teams in a regulated and fast-paced medical manufacturing settingWorked with the Director of Program Management and championed a PMO focus across multiple facilities and implemented best project management practicesDeveloped complex project plans to ensure cost, scope, and timing we met to support international product launches.Coordinated, directed, and led engineering efforts to meet customer program requirements through concept, design, prototyping, and manufacturingWorked with engineering resources to build operating procedures and validation protocols for complex, electro-mechanical devicesDeveloped operational improvement plans for specific strategic programs in multiple manufacturing plants, resulting in a 15% reduction in scrap and decrease of personnel required for particular production linesEstablished COGS reduction strategies and targets leading to implementing strategic sourcing initiatives on critical programs leading to decreases of costs by 9% in the supply chainWorked directly with top-level customer and internal executives to determine production launch schedules and requirementsCapital budgeting analysis/discounted cash flows for adding and replacing machinery equipment and productsManaged a team that included manufacturing engineers, quality engineers, project engineers, senior tooling engineers, production scheduling, and customer service representativesCreated and monitored timelines and status reports for meetings with internal and external customers at all levels.Initiated planned, executed, monitored, controlled, and closed projects within the scope of medical and environmental constraints Conducted risk and profit and loss analysis to decrease impacts on project schedules and budgetsHelped work through design iterations and analyze program impacts with engineers through the development on an assembly that exceeded industry standard tolerances

Worked with executive management to develop marketing and branding strategy development and implementationEstablished marketing documents, requirements, and developed business development plans for strategic marketsDefined, monitored, and managed project scope, timelines, and deliverables from project initiation to finishScheduled, planned, and documented meetings to assess issues, propose resolutions, and track progressTook a large part in helping build the organization by constantly partaking in continuous improvement events, processes, and increasing quality controlsDesigned quality systems revolving around complex medical device programs leading to decreases in scrap and improved strategic relationships Served as a point of contact for customers and vendors to ensure overall quality of services and deliverablesHelped design, implement, and manage a sales call center with the corporationAnalyzed capital equipment needs and conducted budgeting analysis and research for new equipment and processesEntered, updated, mined, and modified data in an SQL database and ERP system to ensure project, inventory, and accounting accuracyAnalyzed material and labor trends to manage logistics, procurement, and operations

Interviewed, trained, managed, evaluated, and scheduled a team of over ten employeesProcessed and reported performance plan to store associates and corporateBalanced invoices and managed vendor relations and deliveries to support profits to ensure inventory control for increased profitabilityFloated between stores in Colorado, implementing improvement to areas of operations and employee relations to increase morale and productivity while managing seasonal changes and projects. Efforts resulted in decreases of inventory by 34% at some sites and increases in sales by 4%

Mapped, fielded, and utilized Java programming while managing a team of developers to manage automated online form servicesRequired to perform projects to the technical specifications and within the scope of insurance regulations and implementationParticipated in and managed daily meetings with other employees to discuss projects and process improvement in a start-up environment