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—this is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, but 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 mediocrity. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
YOUR ROLE
The Kidney Care R&D - Stability team supports R&D projects for new and existing products. We currently have an opening for a Research Associate II to represent Kidney Care Solutions as a Stability Subject Matter Expert. The successful candidate would apply sound chemistry and stability planning knowledge to identify and evaluate stability indicating characteristics as part of product changes and new product development. The effective integration of chemistry and stability enables the establishment of shelf life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global scale. The Stability Subject Matter Expert designs strategies and makes recommendations that may be non-routine to address technical, regulatory, and business requirements.
WHAT YOU WILL BE DOING
1. Represent R&D-Stability on project teams as a member of the project teams' goals and success.
2. Support development and implementation of stability strategies for new product development and sustaining project activities.
3. Support development of GMP stability studies used to establish expiration dating and support labeling for product development.
4. Contribute to the development of technical justifications for expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners.
5. Provide valuable input to stability assessments and requirements for new products and/or current product changes.
6. Ensure the right methods and specifications are available for stability, compatibility, and release testing. Ensure that the methods are appropriate for the product design over shelf life.
7. Demonstrate the ability to identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale.
8. Interact with manufacturing facilities to acquire information related to test methods and specifications.
9. Author, review, and verify technical data, protocols, and reports through use of Quality Documentation System.
10. Act as study director for stability projects under guidance of senior Stability team members.
11. Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry.
12. Support development of new and/or optimization of existing processes and procedures to enhance stability related practices.
13. Participate in investigations that correspond to atypical, out-of-specification, or out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data under guidance of senior Stability team members.
14. Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles.
15. Contribute to stability sections intended for submission to regulatory authorities under guidance of senior Stability team members. Use computerized systems to retrieve, evaluate, and summarize data for reporting.
WHAT YOU WILL BRING
1. Under guidance of senior Stability team member, able to organize complex information and demonstrate attention to detail.
2. Logical and methodical when solving problems, developing solutions, and making sound recommendations with limited input from senior team members.
3. Experience working with sophisticated databases.
4. Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools.
5. Good technical writing skills.
6. Proficient in analytical chemistry including theoretical knowledge and practical experience.
7. Willingness to contribute efforts beyond own scope of responsibilities to ensure project milestones are met.
8. Basic functional understanding of FDA, ISO, and Quality systems.
9. Works well in a team environment across multiple time zones and demonstrates an inclusive attitude.
Education and/or Experience
Bachelor's Degree with 2-4 years or Master's degree in a relevant scientific subject area.
Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
Compensation and Benefits
We understand compensation is an important factor as you consider the next step in your career. The estimated base salary for this position is $60,000 to $132,000 annually, reflecting market data and other factors. Individual pay is based on location, skills, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.
US Benefits at Vantive
Vantive offers comprehensive compensation and benefits packages including health coverage starting day one, retirement plans, paid time off, and additional perks. For more details, please contact your recruiter or visit our Benefits site: Benefits | Vantive.
Equal Employment Opportunity
Vantive is an equal opportunity employer. We evaluate qualified applicants without regard to legally protected characteristics. Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodation
We are committed to providing reasonable accommodations for individuals with disabilities. If needed, please submit your request through the provided form link.
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