Research Scientist I - Stability SME

Vantive • Oakdale, MN

5d • $128,000 - $160,000 • Hybrid

About The Position

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 Scientist I, 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.

Requirements

• Bachelor’s degree in a scientific discipline with 9-13+ years, Master’s degree with 7-11+ years, or PhD with 4-8+ years of experience in relevant discipline is required.
• Ability to organize complex information and demonstrate attention to detail.
• Ability to make decisions when provided with limited information and to make routine decisions independently.
• 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.
• Possess strong verbal and technical writing skills.
• Possess a good understanding of ICH, CPMP, USP, EP, Asian guidelines and cGxP practice in addition to US and EU stability regulations, ISO requirements, and Quality systems.
• Possess proficiency in analytical chemistry including theoretical knowledge and practical experience.
• Willingness to contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
• Willingness to work in a team environment across multiple time zones and demonstrates an inclusive attitude.
• Ability to apply quality principles to work practices.

Responsibilities

• Represent R&D Stability on project teams as a key member to achieve the project team’s goals and success.
• Design and implement stability strategies for new product development and sustaining projects.
• Design GMP stability studies used to establish expiration dating and support desired product labelling for product development.
• Develop technical justifications for setting expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners.
• Perform stability assessments to determine/evaluate requirements for new products and/or current product changes.
• Ensure the right methods and specifications are used for stability and release testing.
• Ensure that the methods are appropriate for the product design over shelf life.
• Identify risks, issues, and opportunities for improvement of existing processes, technologies, and approaches. Provide sound scientific rationale.
• Interact with manufacturing facilities to acquire information related to test methods and specifications and historical stability data, where appropriate.
• Act as study director for stability projects and perform stability data trend analyses on stability studies for new, modified, or sustaining products. Study director responsibilities include authoring, reviewing and/or verifying technical documents and data.
• Plan, coordinate and oversee the progress of multiple Stability related projects of moderate complexity, including budget forecasting, and activities working with global teams and CROs as applicable.
• Responsible for ensuring requirements for sample shipments between the manufacturing and testing facilities, including CROs.
• Author stability sections intended for regulatory submissions that are technically sound and comply with regulatory and industry standards.
• Collaborate with stakeholders to assist in successful completion of method transfer/validation/verification activities on time to facilitate execution of R&D stability studies on schedule.
• 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.
• Utilize in-depth knowledge and understanding of cGxP and related regulations and guidance, to provide expert advice and/or actively participate in the generation, review, adoption and interpretation of such regulations.
• Develop new and/or optimize existing processes and procedures to enhance stability related practices.
• Support junior members working in R&D stability.
• Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level