Research Associate III - Stability SME

Job Description

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.

YOUR ROLE

The Drug Products and Sciences R&D Stability team supports research and development projects for new and existing products.  The Research Associate III, Stability Subject Matter Expert, applies sound chemistry and stability planning expertise to identify and resolve stability indicating characteristics.  The effective integration of chemistry and stability enables 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 develops and designs strategies and makes recommendations that are non-routine to address technical, regulatory, and business requirements.

WHAT YOU WILL BE DOING

Represent R&D–Stability on project teams as a key member of the project teams’ goals and success.

Craft and implement stability strategy plans for new product development and sustaining projects.

Design GMP stability studies used to establish expiration dating for product development.

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.

Provide valuable input to stability assessments and requirements for new products and / or current product changes.

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.

Demonstrate the ability to identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale.

Interact with manufacturing facilities to acquire information related to test methods and specifications.

Author, review and verify technical data, protocols, and reports.

Act as study director for stability projects under guidance of senior Stability team members.

Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry.

Develop new and / or optimize existing processes and procedures to enhance stability related practices.

Participate in investigations that correspond to atypical or out-of-specification / out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data.

Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles.

Optimally plan, coordinate, and oversee the progress of multiple Stability related projects, budgets, and activities working with global teams and CROs as applicable.

Contribute to and / or take lead author role for stability sections intended for submission to regulatory authorities. Use computerized systems to retrieve, evaluate, summarize data for reporting.

WHAT YOU WILL BRING

Bachelor’s Degree with 5-7 years, Master’s with 3-5 years, or PhD with 0-3 years’ experience in a relevant scientific subject area.

Ability to organize complex information and demonstrated attention to detail.

Apply a logical, methodical approach in independently solving problems, developing solutions, and making sound recommendations.

Experience working with sophisticated databases.

Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools.

Good technical writing skills.

Possess proficiency in analytical chemistry including theoretical knowledge and practical experience.

Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.

Functional understanding of FDA, ISO, and Quality systems.

Willingness to work in a team environment across multiple time zones and demonstrates an inclusive attitude.

Vantive is committed to supporting the need 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.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 - $120,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future.  The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently.  The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site : Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status or any other legally protected characteristic.

Know Your Rights : Workplace Discrimination is Illegal

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

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