Research Associate III (PDO)

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.

 Job Responsibilities:

• Act as Solution Lead and Technical expert for new product development projects and lifecycle management activities within R&D Kidney Care Drug Products Organization.
• Organize, plan and execute product development or sustaining activities in compliance with current QA/ environmental/ regulations and standards.
• Provide technical leadership, mentor and guide the execution scientists in order to get tasks accomplished according to plans, milestones and business needs.
• Review and approve Design Control documentation as per the quality procedures and industry standards.
• Establish, maintain and update technical specification describing product appearance, characteristics and functions, and associated verification and validation documents
• Organize, plan and follow the execution of product changes, supplier changes and labelling tasks related to product development or life cycle management projects.
• Support Product Risk Owners with the Design related information and associated failure modes and risks arising from any of the design changes for a given product family
• Support worldwide product registration and launch following international/regional/national regulations; provide technical support to authorities’ questions
• Provide resource estimation and forecast to the project managers or project leaders.
• Ensure good internal and cross-functional communication at a global front and regular status update of projects

Qualifications and Skills

• Master’s in chemistry or M. Pharm. with at least 10-12 years of relevant experience or Ph.D. in pharmaceutical or relevant sciences discipline with at least 7-10 experience in solution development of parenteral formulations.
• Excellent English verbal and written communication skills
• Exposure to medical devices and drug products
• Good knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service
• Good knowledge of Design Control documentation and process
• Demonstrated project/program leadership in drug/pharmaceutical products
• Exposure to Product Risk Management for medical devices and drug products
• Working knowledge of international/regional/national regulations and standards
• Experience in project management and stakeholder management at a global front
• Must be able to able to carry out strategy and vision set by upper management and be able to communicate the vision to more junior associates.
• Ability to work independently.

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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