Experience

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  Aksys ltd.

  Oct 1995 - Jan 2000

  Engineer/senior engineer, chemical systems – r&d

  Completed the manufacturing transfer to a contact manufacturer for concentrates. Validated the dialysate formulations, packaging of concentrates, and the water treatment system.

• 

  Baxter international inc.

  Jan 2000 - Sept 2022

  • Served as the Franchise Pillar Lead for PMO, managed a $50M R&D budget for the Infusion Systems Business portfolio, leading a team of 7 Project Managers and globally dispersed teams in India and the US.• Ensured the successful launch of Baxter's latest Infusion System in the US and Canada.• Developed product and technology roadmaps in alignment with business strategies, working collaboratively with Commercial, R&D, and Medical Affairs leaders to drive innovation and lifecycle management.• Demonstrated expertise in full product lifecycle management, regulatory compliance, and design control, underpinning the successful navigation of the regulatory landscape.• Implemented a KPI-driven metric system for monitoring OPEX and CAPEX budgets, achieving operational cost execution within +/- 3% of the plan, showcasing a deep understanding of governance and financial management.• Leveraged ability to communicate effectively at all levels, complemented by solid knowledge and experience in dialysis, anesthesia, critical care, and fluid systems products and therapies, enhancing the business's strategic position and market competitiveness. Show less • Built and led a global R&D team of over 50 professionals across 3 sites in India, New York, and Illinois, fostering a high-performing culture within a complex, global, and matrixed environment.• Excelled in organizational, people, and project management, with a strong focus on developing leadership skills through mentoring and coaching, leading to the promotion of 4-5 team members and the implementation of a new R&D methodology.• Managed a global R&D budget and resources of $50M/year, driving strategic planning and execution for product portfolio development, including the introduction of agile development practices and leveraging Bio Design principles for innovation.• Instituted an agile product development culture, taking direct ownership of front-end user research and user touch points throughout the product life cycle, and successfully managed 11-12 labs to ensure on-time product launches.• Integrated complex information to provide strategic direction, demonstrating strong problem-solving skills and the ability to enhance the organization's strategic position and market competitiveness. Show less • Ensured the successful launch of Baxter's latest Infusion System in the US and Canada since January 2000.• Spearheaded on-time and on-budget launch of Baxter's flagship Infusion Pump development program. • Led global Access/Elastomeric Project Management Office (PMO) team, enhancing project execution and team performance across the board.• As Franchise PMO Lead for the Access business, optimized portfolio management by strategically reducing product codes by 40%, directly overseeing a $650M product portfolio, and demonstrating expertise in developing and sustaining a wide range of products including sterile products, container closures, hardware, and disposables. Show less • Secured 22 patents, earning a prestigious R&D Award as the only woman recognized for holding over 20 patents, showcasing innovation and leadership in healthcare product development.• Led a cross-divisional team of 50+ employees and external partners to develop a groundbreaking water treatment device for home dialysis systems, achieving Baxter's first CE Mark approval for such a device due to expertise in global partnership management.• Pioneered Baxter's first comprehensive translation process for home hemodialysis system labeling that was adopted organization-wide and played a pivotal role in securing FDA approval for acid concentrates for hemodialysis. Show less • Managed a high-visibility remediation project across Columbia, EU, Brazil, and Mexico with a multidisciplinary, global team, leading to the timely completion of critical objectives.• Drove development of a new disposable product for Baxter's dialysis instrument from exploratory to feasibility stages, while directly overseeing the work of two engineers, demonstrating significant leadership in product innovation.• Participated as a voting member on the AAMI Renal Disease and Detoxification Committee for 2 years.• Developed employee training modules for the Renal R&D department, optimized team structure for agility, and led dialyzer product line to implement product modifications that cut complaints by 75%.• Provided technical guidance to the Joint Venture Board between Baxter and Gambro for 3 years and represented the PMO in quarterly Joint Management meetings.• Introduced validation process for consumables integrated with Baxter dialysis systems, setting standard for process adaptation company wide. Show less

  • Director of Program Management

    Sept 2021 - Sept 2022

  • Director, Engineering/Sr. Manager

    Jun 2018 - Sept 2021

  • Senior Project Manager - Fluid Systems Franchise

    Dec 2014 - Jun 2018

  • Senior Program Manager -Surgical Care Franchise

    Jul 2013 - Dec 2014

  • Senior Project Manager (Lead Project Integrator)- Renal

    Jan 2007 - Jul 2013

  • Engineering Specialist/Sr. Principal/Principal Engineer (Disposable Engineering Lead) – Renal R&D

    Jan 2000 - Jan 2007
• 

  Horizon

  Oct 2022 - now

  Program and project management

  • Spearheaded an Early-Stage Drug Development Program, managing a $35M budget and collaborating with a globally dispersed team across the EU and US, ensuring quality and medical writing documentation for 8 products by working closely with product teams and vendor management to increase capacity through resource addition and process optimization.• Orchestrated logistics for Governance Mechanisms, including the Technical Review Forum (TRF) and Clinical Trial Review Board (CTRB), enhancing operational efficiency and stakeholder engagement.• Initiated and led a special project as the Program Management Lead for Medical Writing, serving as the primary liaison between R&D asset teams and vendors, significantly improving communication and project delivery timelines.• Designed and implemented a portal for the Medical Writing Inventory, establishing a streamlined process for its execution, thereby enhancing accessibility and project management capabilities. Show less