Research Associate II

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our 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.

*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

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, and designing analytical methods 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 a working knowledge of basic technical theories and principles within the 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 the registration of R&D Products.

• 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) and nonconformance/deviations to identify sound scientific root causes 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, and issues, and identify opportunities for improvement of existing processes, technologies, and approaches by providing a 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.

Qualifications:

• Strong knowledge of regulatory validation & stability guidelines and skills for testing products within relevant disciplines.

• Possess relevant good practical knowledge of analytical techniques like HPLC/UPLC, GC, Titrations, AAS, etc.,

• Possess relevant laboratory/technical, writing, and computer skills.

• Able to work in a team environment appropriately supporting others.

• Self-motivated and takes personal responsibility for getting the job done.

• Ability to objectively assess, organize, and communicate complex information.

• Understand the importance of project schedules and contribute to efforts beyond their scope of responsibilities to ensure project milestones are met.

• Ability to adapt to shifting priorities.

• Ability to demonstrate critical thinking and problem-solving skills.

• Handling of software like Empower, Chromeleon, LIMS, etc.,

• Good learning agility and communication skills.

• Possessing relevant computer and technical skills including M.S Word, spreadsheets etc.

Bachelor’s degree with 8-14 years or Master’s degree with 5 to 10 years of experience in a relevant scientific discipline

(Analytical chemistry/Pharmaceutical chemistry)

Reasonable Accommodations

Baxter 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.

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