Associate Director ELMAT

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.

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

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

The Kidney Care portfolio consists of drug products including Chronic Renal Care solutions, Acute Therapy, and medical devices including e.g. electromechanical devices, disposables and dialysis filters.

This leader directs a team of approximately 35 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 activities. The leader will have ~ 6 direct reports that will include ~ 4 people leaders with teams and senior SMEs. This role involves developing innovative methodologies to meet regulatory and scientific standards for ELMAT, working cross-functionally with various R&D and product teams. This role reports to the global Sr. Director for the Sciences organization (which includes other competency areas such as Analytical Chemistry, Stability, Preclinical and Sterility) within Kidney Care R&D.

Essential Duties and Responsibilities

• Prioritize, direct, and own all ELMAT activities 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 ongoing projects.
• Lead a team of people leaders and senior SMEs to define ELMAT strategy for the problem at hand, help identify testing matrix, approve reports about ELMAT 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 ELMAT studies – from strategy to answering any queries from the regulatory authorities.
• Develop and communicate a vision for ELMAT and translate it into a concrete strategic plan. Inspire the team to take actions consistent with that vision. Set high standards and goals and remove barriers to excellence.
• Collaborate and work closely with peers, e.g. functional leaders for areas like Analytical Chemistry, Sterility, and Preclinical, to align ELMAT goals and strategy with other functions so as to meet project and organization goals in a most efficient and effective manner.
• Collaborate and influence cross-functional peers and senior leaders in product design, regulatory, medical affairs, legal, commercial, and quality to achieve organizational goal to provide safe drug and medical device products to our global patient population.
• Act as a thought leader in global ELMAT community by encouraging and enabling participation of their team members in external working groups that define & influence technical direction of ELMAT 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, develop plans that incorporate global and regional business practices and customer requirements. Ensure team objectives support key business programs.
• Track and own 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.
• 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

An educational background in Chemistry, Polymer science &/or engineering is required for this role.

A master’s degree with 15+ years of relevant experience is required for this role, or Ph.D. with 11+ years of relevant experience will be preferred.

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.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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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