Job Description

Vantive: A New Company Built On Our LegacyBaxter 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 dont 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.Job Summary

• Job Title - Research Scientist I, Analytical Chemistry Lead
• Grade - 18
• Location - Whitefield, Bengaluru
• Shift - General

Baxter has long been on the forefront of developing innovative solutions for patients with kidney disease. This job offers a unique and exciting opportunity to contribute in the design, development and life cycle management of Baxters Kidney Care systems.Establish Analytical business strategies and act as an analytical lead of large, complex projects. Participate in various projects by designing experiments, independently developing/evaluating/validating and/or transferring analytical methods and performing risk and gap assessments. As a senior analytical lead, collaborate across functions and regions as well as coach, mentor, and inspire junior members of the team.Essential Duties and ResponsibilitiesWithin the context of product development

• Conduct or advise on technical feasibility analysis of complex research and design concepts.
• Independently design and execute experiments that address multiple variables and require advanced techniques.
• Lead the evaluation of current methods and devise innovative approaches through adaptations and incorporation of modern technologies to meet business objectives such as quality and cycle-time.
• Collaborate with global teams across various functions (ex. quality, regulatory, operations, manufacturing, etc.).

As an analytical method developer

• Collect information for the analytical target profile.
• Propose techniques and develop analytical methods independently.
• Analyze data, make decisions, and present status at technical review meetings.
• Advise and troubleshoot issues and propose solutions.
• As study director, design complex studies and autonomously write protocols, reports, and procedures. Contribute to technical feasibility analysis of complex research and design concepts, execute studies such as exploratory studies, development, validation and transfer of analytical methods as on when required. Support analytical problem-solving efforts to meet urgent business needs.
• Conduct and advise on evaluation, validation, or transfer of analytical methods, including investigating failed acceptance criteria. Leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles.
• Write validation and method summaries for regulatory submissions without assistance.
• Write clear responses to authorities questions on analytical methods.

As an analytical leader

• Represent Global R&D-Analytical on project teams as a key part of the project teams goals and success.
• Collect and analyze information related to product, specification, validations, timelines, release, and stability sites to build the Analytical Business Strategy for new product development and sustaining product projects.
• Identify risks, issues, and opportunities.
• Anticipate and communicate delays and propose solutions.
• Establish external partnerships, and oversee work done at contract research organizations.
• Evaluate resource needs and program analytical budgets.
• Plan, schedule, and drive analytical activities across sites for complex projects.
• Leads the analytical transfer plan globally to manufacturing plants, CRO and other R&D centers
• Employ appropriate techniques/methods to successfully and independently implement analytical activities within negotiated deadlines.
• Make decisions related to Analytical Chemistry
• Anticipate and pro-actively address questions from authorities.
• May own global procedures and processes relevant to the analytical chemistry domain.
• Coach and mentor junior members working in various analytical activities and leadership.

Qualifications

• Strong knowledge of analytical techniques with experience in development, validations, or investigation on analytical methods.
• Expertise in statistical analysis to understand analytical method performance.
• Knowledge of chemistry (spectroscopy, chromatography, wet chemistry, and solution mixing).
• In-depth knowledge of relevant QSRs, GxP, and other regulatory requirements including ICH and pharmacopeia.
• Experience with cross functional/cross regional projects.
• Execution-focused for planning/tracking/anticipating and mitigating risks/challenges.
• Critical thinking, innovative mindset, curious, with demonstrated learning agility.
• Team Player and active participation in the technical forums.
• Quality-oriented and having critical mind and scientific curiosity.
• Skilled in the areas of managing priorities, stakeholder and conflict management.
• Agile and can shift gears comfortably.
• Basic computer skills (MS Office Word, Excel, PowerPoint, etc.) plus Empower, electronic lab notebook, and Minitab.
• Excellent English speaking, reading, and writing skills.

Education/Experience: Ph.D. in chemistry-related field, with minimum 10+ years relevant experience or master's degree with minimum 13 years of relevant experience in pharmaceutical or medical devices space.Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

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