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.

This position is responsible for
•Conducting laboratory testing, not limited to validation, verification, transfer, and registration stability studies. The successful candidate shall possess solid “hands-on” technical abilities, a passion for their work and the impact it has on meeting the needs of patients.
•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 minimal 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 minimal 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 minimum guidance.
•Support in writing responses to authorities’ questions on analytical methods.

Reasonable Accommodation

Vantive 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 link here and let us know the nature of your request along with your contact information. Form Link

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