Research Associate Ii

6 months ago

Bengaluru Karnataka, India BAXTER Full time

**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.This position is responsible for

Effectively contributing technical knowledge and skills to a variety of projects by conducting testing, designing analytical method and experiments.

Interacting effectively with a variety of disciplines (Quality, Regulatory, External partners etc.).

Conducting routine research and design experiments, independently developing/evaluating/validating and/or transferring analytical methods.

Essential Duties and Responsibilities:
Collect information for the analytical target profile.

Propose techniques and develop analytical methods independently.

Design studies and write protocols, reports, and procedures with mínimal guidance.

Evaluation, validation, or transfer of analytical methods, including investigating failed acceptance criteria.

Contribute routine scientific knowledge or expertise to research and development activities for achievement of project goals.

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.

Independently conduct routine research and developmental activities. Plan details of assigned tasks within specific parameters.

Employ appropriate techniques and methods to successfully conduct assignments within negotiated deadlines after receiving general instruction.

Perform laboratory testing in a regulated environment.

Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks.

Develop knowledge and understanding of GxP and related regulations and guidance.

Conduct R&D stability testing as per the stability protocol to support registration of R&D Product.

Independently execute analytical method validations and transfers with mínimal support.

Accurately test the samples (Right First Time) and assess results for conformance to specifications.

Manage Laboratory investigations (OOS/OOT), Nonconformance/deviations to identify sound scientific root cause to follow the implemented corrective and Preventive actions.

Sample receiving and data entry in LIMS.

Adhere to cGxP requirements (ALCOA+), Data Integrity, Quality Culture and Compliance Level.

Own SOPs of relevant techniques / procedures.

Advise and troubleshoot issues and propose solutions.

Maintain lab equipment and report on malfunctions.

Good knowledge of laboratory health and safety standards.

Demonstrate the ability to identify risks, issues, and identify opportunities for improvement of existing processes, technologies, and approaches by providing sound scientific rationale.

Maintain knowledge of relevant QSR and other regulatory requirements related to R&D to ensure compliance in all research, data collection and reporting activities.

Collaborate with global teams across various functions (ex. quality, regulatory, operations, manufacturing, etc.).

Analyze data, make decisions, and present status at technical review meetings.

Design studies and autonomously write protocols, reports, and procedures with

**Reasonable Accommodations**

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