Research Scientist I

2 days ago

Bengaluru Karnataka, India Vantive Full time

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.

**SUMMARY**

**Essential Duties and Responsibilities**:

- Participate in E&L change control impact assessments when applicable to trace analysis and work with cross functional team members (design owners, E&L and materials SMEs, preclinical & toxicologists, etc.) to determine a comprehensive testing strategy through writing impact assessments, gap assessments, technical rationales and documents related to such change controls.
- Interact across functions (Design Owning Organization, Project Management Organization, Regulatory Affairs, Preclinical, etc.) to understand products and therapies, as well as business, technical, and regulatory requirements to meet project needs.

**Qualifications**:

- Knowledge of regulatory expectations related to trace analysis for drugs and devices.
- Performing change control in a GMP environment.
- Experience of working in global cross-functional teams for trace analysis projects
- Independent problem solver who can use a methodical approach to develop solutions and make recommendations.

**Education and/or Experience**:

- Post graduate degree/ PhD (M Pharm, MSc, MS) in scientific discipline (Pharmaceutical, Analytical or Organic chemistry preferred) with a minimum of 10 years of experience.

**Reasonable Accommodation**

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