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 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.
Summary of responsibilities
Participate in a variety of projects by conducting testing, designing experiments, independently developing/evaluating/validating and/or transferring analytical methods.
Analytical lead of complex and/or large size projects.
Essential Duties and Responsibilities Within the context of product development
Contribute to 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 new approaches through adaptations and incorporation of new technologies to meet business objectives such as quality and cycle-time.
Collaborate with global teams across various functions (ex. quality, regulatory, operations, manufacturing, etc.).
Perform laboratory testing in a regulated environment.
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.
Design complex studies and autonomously write protocols, reports, and procedures.
Participate in evaluation, validation, or transfer of analytical methods, including investigating failed acceptance criteria.
Write validation and method summaries for regulatory submissions without assistance.
Write clear responses to authorities questions on analytical methods.
As an analytical leader
Collect and analyze information related to product, specification, validations, timelines, release and stability sites to build the Analytical Business Strategy.
Support the Technical Lead by planning analytical activities for different sites.
Actively participate in technical team meetings.
Anticipate and communicate delays and propose solutions.
Establish external partnerships, and oversee work done at CROs.
Evaluate the number of resources required for each analytical activity.
Make decisions related to Analytical Chemistry, pro-actively address questions from authorities.
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.
Basic computer skills (MS Office Word, Excel, PowerPoint, etc.) plus Empower, electronic lab notebook, and Minitab.
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.
Excellent English speaking, reading, and writing skills.
Education: Masters in Analytical Chemistry, Pharmaceutical analysis, Organic Chemistry, Biosciences with 5 to 8 years of experience post Masters.
Reasonable Accommodations
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