Research Scientist 1 - Extractables and Leachables

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:

The successful candidate for this role will be part of materials, chemical characterization and E&L team and will bring hands-on and technical leadership experience in trace analysis like E&L and Nitrosamines for medical device and drug products. This Research Scientist role will entail utilization of expertise in analytical chemistry, mass spectrometry and other related techniques to perform gap assessments for medical device and drug products requirements and support change control activities across the Renal and Acute Care businesses within Vantive.

The successful candidate is expected to also have a strategic mindset and will work closely with regulatory, quality, preclinical and product design owning leaders to enable investigations and characterization of trace impurities in drugs & devices to support on-market or new product programs. This role will also include planning and performing laboratory work in mass spectrometry including execution of laboratory studies at in-house laboratories and supervising in external CRO labs. The candidate will likely act as study director for multiple studies at any given time and is expected to have excellent skills in wet chemistry, spectroscopy, chromatography, mass spectrometry to enable efficient and effective execution of programs. The individual will author required reports (internal documentation and regulatory submissions) following pertinent internal and external guidelines that ensures safety and compliance of drugs or devices that Vantive makes. The candidate is expected to stay abreast of emerging sciences and technologies that influence chemical characterization for medical devices and drug products through active participation in relevant external forums / societies

Essential Duties and Responsibilities:

- Develop and qualify state of the art methods using LCMS/ GCMS/ HRMS for extractable and leachable study of medical devices and drug products.

- Strategize and design E&L study for medical devices and drug products.

- Ability to review complex analytical data pertaining to E&L and other trace analysis. Draw data interpretation and conclusions

- Should have hands on experience with structural elucidation, unknown compound identification.

- Develop strategies to effectively apply a risk-based scientific approach within a regulatory framework to support trace analysis/ E&L projects and change control activities.

- Collaborate with a multidisciplinary team of subject matter experts (e.g. E&L, Materials, Biocompatibility and Toxicology) to develop trace analysis strategies that align to regulatory requirements for medical devices and drug products.

- 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.

- Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization during product development, design and safety.

- 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:

- Demonstrated experience & expertise in Extractables & Leachable with hands-on experience in mass spectrometry (HRMS, LCMS and GCMS) and study design for medical devices and drug products.

-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:

- Ph.D. / Post graduate degree(M Pharm, MSc, MS) in scientific discipline (Pharmaceutical, Analytical or Organic chemistry preferred) with a minimum of 10 years of relevant (E&L, Mass spec) experience.

Reasonable Accommodation

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