Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B 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 separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

The Associate Director of Extractables and Leachables within Kidney Care R&D will establish and lead a global team of experienced scientists, subject matter experts(SMEs) and study directors for E&L and the role is based in Bangalore, India. This Associate Director plays a pivotal role in aligning the vision of the E&L organization with business needs, building, and guiding the team toward that vision, and overseeing E&L support at all stages of the product life cycle. These activities ensure that products are safe, pure, and well-characterized during development, at the time of manufacture, and over their entire shelf life.

The Kidney Care portfolio consists of Chronic Renal Care solutions (~10 product families), Acute Therapy solutions (~5 product families), electromechanical devices (7 platforms) and disposables and filters (~100 product families).

This leader directs a team of approximately 6 experienced scientists & SMEs, ensures planning and execution of testing (in-house and with external partners) and collaborates with global colleagues on various on-market product support and new product development activity. The role involves developing innovative methodologies to meet regulatory and scientific standards for E&L, working cross-functionally with various R&D and product teams. This role reports to the global Director for Materials, E&L and Preclinical R&D function within Kidney Care R&D.

Job Responsibilities:

• Prioritize, direct, and supervise all E&L studies  being considered in Kidney Care. The work may be tied to change controls for existing products on the market (due to supplier change or changes in regulations or other business needs) or new product development. The work may also be executed at external partner labs to support on-going projects.
• Lead a team that will act as study directors and SMEs – and thus will define E&L strategy for the problem at hand, identify testing matrix, write & approve protocols and write reports about E&L findings that will be submitted to the regulatory bodies. As a leader of this critical competency, the individual will be responsible and accountable for the entire life cycle of E&L studies – from strategy to answering any queries from the regulatory authorities.
• Act as a global single point of contact and provide technical leadership in E&L as it pertains to E&L strategy for regulatory and environmental compliance for our entire global product portfolio.
• Develop and communicate a vision for E&L and translate it into a concrete strategic plan. Inspire the team to action consistent with that vision. Set high standards and goals and remove barriers to excellence.
• Collaborate and work closely with their peers – which will include – materials and chemical characterization lab managers with resources, capability, and capacity to execute E&L studies in addition to other testing capabilities and SMEs & leaders in preclinical (Biocompatibility and toxicology) function.
• Collaborate and influence cross-functional peers and senior leaders in product design, regulatory, medical affairs, legal, commercial, and quality to achieve organizational goal to providing safe drug and medical device products to our global patient population.
• Act as a thought leader in global E&L community and actively participate in external working groups that define & influence technical direction of E&L and help shape regulatory frameworks.

• Lead talent selection, development, retention efforts, establishing clear criteria for measuring team and individual success. Provide feedback, recognition, and opportunities for cross-training.
• Mentor team members in areas such as scientific excellence, innovation, and internal and external influence, ensuring their developing expertise aligns both with their career interests and with business needs.
• Provide leadership by guiding in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.
• Communicate strategic imperatives to project success, developing plans that incorporate global and regional business practices and customer requirements. Ensure team objectives support key business programs.
• Develop program milestones, schedules, and budgets optimizing financial resources and balancing in-house and outsourced resources.
• Review and implement best practices and team processes to enhance operational efficiency, resolve issues, improve project timelines, and make timely, risk-based decisions. Solicit regular input from customers and take appropriate action. 
• Be accountable for team’s successful completion of projects/tasks and for meeting agreed upon milestones.
• Generate innovative solutions to complex problems leveraging multiple disciplines and technical principles. Develop innovative processes and methods through fusion of expertise.
• Cultivate a professional network both internal and external to the business.
• Maintain current knowledge of Quality System Regulations and other relevant regulatory requirements.

Qualifications

• Must possess strong knowledge of scientific/technical disciplines and solid knowledge or related disciplines such as regulatory, quality, and/or product development. Recognized internally and externally as expert in functional area.
• Must possess knowledge of general quality and business systems.
• Must possess strong leadership and ability to negotiate for resources and influence others internally and externally.
• Must demonstrate mentoring and management capabilities, effective communication, and strong decision-making skills.
• Must be able to set strategic direction for the organization and broadly communicate the vision.
• Must be self-motivated, have excellent interpersonal skills, capable of analytical and solving complex problems through innovative thought and experience, as well as project management tools.

Education and Experience

Bachelors / Masters / P.hd with 18+ years of relevant experience.

Equal Employment Opportunity.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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