Vantive: A New Company Built on Our Legacy
Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.
Summary:
The Lead System Integrator (LSI) team is a part of the R&D organization that supports the Kidney Care business segment. Within the team, we provide R&D focused project management support for all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products challenges and services to patients and continue Baxter’s mission to save and sustain lives.
Baxter is a global company with R&D sites at multiple locations in the world; competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites and with other functional representatives. Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities.
The Kidney Care R&D - Drug Products and Sciences (DPS) organization is responsible for Kidney Care drug products (dialysis solutions, concentrates, etc) and related sciences (Sterility Assurance, Analytical Chemistry, materials compliance, Extractables & Leachables, Toxicology). As a member of the Drug Products and Sciences organization, the Project Manager role leads DPS R&D project activities with their Project Management and Technical Leadership skills. The Project Manager will be responsible for forming project teams and developing effective operating mechanisms. This role may be responsible for multiple simultaneous projects of greater complexity and/or visibility.
Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
Lead research and development (R&D) project management work and facilitate technical decision making for drug products, medical devices, and other regulated healthcare productsOwner of R&D program schedule creation, tracking, and execution. Integrate inputs from all DPS competencies/subject matter experts into a harmonized project proposal, project schedule, technical risk assessment, and other project plans.Drives interactions and resolution of technical issues with other R&D functions and cross-functional interfaces for complex projectsParticipates as a member of cross functional teams and/or integrates cross functional inputs into project deliverablesAccountable for project execution and proactive risk management. Effectively tracks project status, risks, budget, and external spend.Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standardsPrepares project reports, analyses and delivers presentations to R&D leadership on a regular basisLeads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the projectEstablish project communication channels and archives. e.g., Teams group, Status meetings, Escalation matrix, etc. Facilitate/organize DPS R&D project design reviews and similar decision meetings Facilitate purchase orders (POs) and approve corresponding invoices for the R&D tasks executed by external vendors (e.g., external labs, translation agencies, etc.) Across multiple parallel projects, identify and evaluate interactions/dependencies and potential synergy opportunitiesQualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
Deep experience in project management principles and methodologies; multiple cycles of successful product development experiencesStrong interpersonal and communication skills in written and verbal formDemonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc.).Ability to provide technical leadership and coordination for medical product projects with substantial complexity and scope.Ability to decompose complex problems into actionable plans and track them to closureUnderstanding of design requirements for development, validation, and verification of medical productsEducation and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
Bachelors degree in Engineering, Science or equivalent field14+ years of R&D experience; 12+ years project management experienceExperience in pharmaceuticals or medical device industry strongly preferredReasonable Accommodations
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