Research Associate Ii

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

**Job Summary**
- **Job Title - Research Associate II, Life Cycle Management (LCM) Scientist**:

- **Location - Whitefield, Bangalore**:

- **Shift - General**

**Essential Duties and Responsibilities**:

- Represent Global R&D-Analytical on project teams as a key part of the project teams’ goals and success.
- Develop and execute analytical plans for new product development (NPD) and sustaining product projects (SPO)
- Execute lab activities related to analytical method development, validation, and transfer of methods to within/other R&D/manufacturing sites to support business needs.
- Ensure laboratory compliance and follow best practices.
- Represent R&D - Analytical as member of project teams. Actively participate in success of project team goals
- Identifies and plans for all analytical resources needs capabilities and capacity required for the execution of the analytical strategy plan.
- Support and lead the analytical transfer plan globally to manufacturing plants, CRO and other RD centers.
- Without assistance, make sound technical recommendations regarding analytical method validation, transfer and testing that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
- Employ appropriate techniques/methods to execute routine analytical activities successfully and independently within negotiated deadlines. Identify alternative methods and technologies for improving existing or new products/processes.
- Act as a study director for these designs and execute method validation and transfer studies.
- Perform analytical gap assessment of in-use analytical methods and provide strategic action plan to remediate.
- Contribute to technical feasibility analysis of complex research and design concepts, execute studies such as development, validation, and transfer of analytical methods as on when required. Support analytical problem-solving efforts to meet urgent business needs.
- Prepare and review analytical documents (Validation/Transfer/Development protocols/reports, special reports) in compliance with analytical methods, global and local procedures.
- Contribute to Analytical sections intended for submission to regulatory authorities and responses to authorities.
- Demonstrate the ability to identify risks, issues, and opportunities.
- Support the analytical problem-solving efforts to meet urgent business needs and contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
- Support and prepare investigation plan for validation/transfer failure, OOS, deviations, and Incidents. Leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles.
- Demonstrate the ability to identify risks, issues, and opportunities.
- Collaborate with other global functions, such as project management, regulatory, formulation, manufacturing, external supplier, external partners, and quality control in project teams to ensure successful execution of analytical testing and study designs.
- Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
- In addition to having an in-depth knowledge and understanding of current regulatory guidelines, cGxP and related regulations and guidance, can provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations. Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
- Coach and mentor junior members working in analytical activities not limited to methods development, validation, transfer, and gap assessment.
- Co-ordinate with technical lead/study director to execute a series of study designs and/or techn