Research Scientist II

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:

This role is aligned within the Solutions and the Containers Team reporting to the Sr. R&D Manager, Drug Products - Americas Solutions and Containers team in the USA. As part of the Product Development Lifecycle Management and Sustaining Product Organization team you will play a key role in defining, organizing, planning, and leading global multi-functional projects related to all the modalities of Kidney care (PD, HD, and Acute). You will work on new product development projects and innovative technologies supporting improving our products, therapies, and patient outcomes. You will propose options and develop action plans for problem-solving and product and process improvements.

This position will work on projects and programs associated with solutions and containers products for all three kidney care modalities: Peritoneal Dialysis (PD), Hemodialysis (HD), and Acute kidney care, and will be responsible for all aspects of product lifecycle management.

What You'll Be Doing:

• Develop and implement project management processes for knowledge and ownership transfer and project and program reporting and tracking
• Define, organize, plan, and execute activities related to new product registration and product design changes in compliance with current international/regional/national regulations
• Support product lifecycle management and Sustenance organization in the area of medical devices and drug products
• Propose options and develop action plan for problem-solving, product and process improvement
• Participate in multi-functional and international project team for effective collaboration and deliverables
• Coordinate and ensure follow-up of technical activities in collaboration with customers, partners, and team members with respect to project dedication, quality procedures, and business needs
• Work with quality management systems in the field of drug products, medical devices, and related areas
• Establish, maintain, and update technical & design documentation according to Good Documentation Practices
• Ensure good internal and cross-functional communication and regular status update of activities
• Provide mentorship to newer members of the team

What You'll Bring:

• Bachelors or Masters degree in Material Science, Materials Engineering, Chemical Engineering, Biosciences, Biomedical Engineering, or related field
• Minimum of 15 years of diverse industrial experience in the given technical domains
• PMP certification is highly recommended
• Proven track record of large-scale program leadership and project management
• Broad understanding of the overall product and therapy along with deep technical expertise in one or more fields related to drugs, drug products, and/or medical devices
• Knowledgeable with ICH, FDA, relevant cGxPs, ISO, and quality systems associated with pharmaceutical and medical devices development
• Understands the implications of raw material change in pharmaceutical and medical devices industries (product impact, process impact, regulatory implications, end user, sterilization, etc.)
• Proven track record to create results within budget, timeline, and product/project work you're doing
• Knowledge of manufacturing processes and process optimizations for drug products/medical devices preferably in Parentals/combination devices space
• Possess an agile attitude
• Strong technical leadership and prior experience of leading multi-functional projects at a global front
• Expertise in Design Control documentation and medical writing
• Experience with Trackwise, Digital Twin, and other quality tools of interest
• Experience with handling NCR, CAPA and other quality management systems

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.

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 $144,000 to $180,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based 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.

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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