Research Associate I

Reposted 5 Days Ago
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Bangalore, Bengaluru Urban, Karnataka, IND
In-Office
Entry level
Healthtech • Software • Pharmaceutical • Manufacturing
The Role
Conduct laboratory testing and analytical method development, validation, transfer, and stability studies in a regulated R&D environment. Prepare protocols, reports, and procedures; investigate OOS/OOT results and deviations; enter data in LIMS; maintain equipment; and ensure cGxP, data integrity, and regulatory compliance. The role collaborates with quality, regulatory, manufacturing, operations, and global teams while troubleshooting technical issues and supporting project milestones.
Summary Generated by Built In

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 basic technical knowledge and skills to a variety of projects within relevant disciplines.
•Interacting effectively with a variety of disciplines.
•Conducting routine research and design experiments with minimum assistance.
Essential Duties and Responsibilities:
•Collect information for the analytical target profile.
•Propose techniques and develop analytical methods independently or with minimum support.
•Design studies and write protocols, reports, and procedures with minimal guidance.
•Participate in 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.
•Under direction, conduct routine research, developmental activities. Plan details of assigned tasks within specific parameters.
•Understand and apply applicable corporate and divisional SOPs.
•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.
•Execute analytical method validations and transfers with minimal support.
•Accurately test the samples (Right First Time) and assess results for conformance to specifications.
•Support 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.
•Ownership of SOPs of relevant techniques / procedures.
•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.
•Collaborate with global teams across various functions (ex. quality, regulatory, operations, manufacturing, etc.).
•Maintain knowledge of relevant QSR and other regulatory requirements related to R&D to ensure compliance in all research, data collection and reporting activities.
Qualifications:
•Knowledge of regulatory validation & stability guidelines and skills for testing products within relevant discipline.
•Possess relevant practical knowledge on 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 clearly communicate complex information.
•Understand the importance of project schedules and contribute to efforts beyond own 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.

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

Recruitment Fraud Notice
Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Skills Required

  • Knowledge of regulatory validation and stability guidelines, with experience testing products in a relevant discipline.
  • Practical knowledge of analytical techniques such as HPLC/UPLC, GC, titrations, and AAS.
  • Relevant laboratory, technical, writing, and computer skills.
  • Ability to work effectively in a team environment and support others.
  • Ability to objectively assess, organize, and clearly communicate complex information.
  • Ability to adapt to shifting priorities and contribute to project schedules and milestones.
  • Critical thinking and problem-solving skills.
  • Experience using Empower, Chromeleon, LIMS, Microsoft Word, and spreadsheets.
  • Good learning agility and communication skills.
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The Company
5,800 Employees
Year Founded: 2023

What We Do

Vantive is a standalone vital organ therapy company dedicated to extending lives and expanding possibilities for patients and care teams globally. Building on a 70-year legacy in kidney care, Vantive provides innovative therapies, digital solutions, and advanced services for dialysis and critical care. The company operates in over 100 countries, focusing on improving outcomes for millions of patients through its integrated approach to organ support.

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