Research Scientist I

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 Kidney care Solutions and the Containers Team reporting to the Sr. Manager, 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 mainly associated with Peritoneal Dialysis (PD) kidney care solution and container products and will be responsible for all aspects of lifecycle management.

What You'll Be Doing:

• 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
• Provide technical assessment and strategy for product changes related to design, labeling, raw material, manufacturing support, regulatory compliance, quality improvement, and new registrations
• 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 regulatory standards and quality management systems in the field of drug products, medical devices, and related areas
• Provide technical support to authorities' questions in due time
• 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
• Anticipate risks/challenges and willingness to help lead ambiguity
• Provide mentorship to newer members of the team

What You'll Bring:

• PhD (preferred) or Masters (required) in Material Science, Materials Engineering, Polymer Chemistry, Polymer Engineering, Chemical Engineering, Biosciences, Biomedical Engineering, or related field
• Minimum of 10 years of diverse industrial experience in the given technical domains
• 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
• Proven knowledge in the development of polymer materials and formulations
• Expertise in multi-layer composites with sound knowledge of structure property relationships of polymers/materials
• Experience with the development, characterization, and process optimizations for new materials
• 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
• Exposure to material characterization tools, extractables and leachables and REACH complaint materials for drug products/medical devices
• 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 Statistics and Six Sigma tools
• 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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $120,000-150,000. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location. Vantive offers dental and medical insurance, paid time off, parental leave, and more.

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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.