Research Associate I

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

We are seeking highly motivated and technically qualified extractables and leachables (E&L) scientist to execute E&L studies for Vantive’s medical devices. Collaborating with cross-functional teams to develop and implement E&L testing methods in compliance with regulatory guidelines. Staying up to date with industry developments and emerging trends in E&L testing. Candidate should have knowledge of regulatory compliance and guidelines related to E&L testing.

The ideal candidate should have hands-on experience with analytical techniques and instrumentation like mass spectrometry, spectroscopy, chromatography (LCMS 3Q, LCMS-QTOF, GCMS, GCMS-QTOF, ICPMS, UPLC, IC etc.) and demonstrate understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Quality Management Systems (QMS).

Essential Duties and Responsibilities.

This position provides hands-on Analytical Research and Development support in the laboratory under supervision to the R&D activities, particularly to Extractable and Leachable testing.

• Execute method development experiments, method validations/ qualifications.
• Perform experiments to support new product development and sustaining product projects.
• Work collaboratively with senior members of the team in activities such as sample preparation for analysis and operation of advanced analytical instruments based on various Chromatographic and Spectrometric and allied methods.
• Own equipment ownership, calibration and maintenance of equipment in the laboratory.
• Apply theory & principles and technical learnings to execute projects/ develop and improve methods and products.
• Be innovative. analyze and propose solutions to research problems.
• Recommend new analytical techniques to enhance the lab capability and productivity.
• Document laboratory work performed per Vantive’s GDP, strictly adhering to ALCOA plus principles.
• Work in compliance to current industry standards, regulatory guidelines (e.g., Data Integrity, ALCOA, ICH, ISO)
• Follow Vantive’s Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day-to-day activities, to ensure proactive compliance and continuous improvement.
• Participate in Vantive’s corporate social responsibility, imbibe the values and culture.

Qualifications.

• Understanding (working principles, instrumentation, potential applications) of hyphenated- chromatographic techniques (e.g., GCMS, GC-QTOF, LCMS, LCMS-QTOF, ICPMS)
• Good understanding of (complex) sample matrix, applicable separation methodologies and influence of sample matrix on analytical methodology/ interferences.
• Theoretically strong in spectrometric techniques like mass spectrometry & related advanced techniques and spectroscopic techniques (e.g., GCMS, GC-QTOF, LCMS, LCMS-QTOF, ICPMS)
• Hands-on experience in operation of analytical tools/ laboratory instruments (e.g., balances, pH meter, oven, centrifuge, water bath, sonicator, shaker etc.)
• Good understanding of basic wet chemistry techniques like weighing, serial dilution, pipetting techniques, sample preparation, pH measurement, filtration, evaporation, liquid- liquid extraction etc.
• Knows the formulation concepts of large volume parenteral and chemistry of solid - liquid interfacial behavior of PVC and related container closure system, generation of leachables.
• Should have high learning agility, adaptability and innovative mindset along with good presentation skills, team connect and collaboration.
• Excellent written and verbal communication skills in English.
• Ability to objectively collect, assess, organize and clearly communicate information.
• Understands the organizational priorities, commits to work assigned and meets project deliverables in a timely manner.

Education and/or Experience necessary to perform the job satisfactorily.

Graduate/ Postgraduate/ PhD in Pharmacy/ Chemistry or related field (M. Pharm./ M. Sc./ PhD) with 3-7 years of relevant experience.

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.