- Act as Product Design Owner (PDO) within its product family and technical expert for projects in development and lifecycle management activities within R&D Kidney Care Solutions Development
- Organize, plan and execute sustaining activities in compliance with current QA/ environmental/ regulations and standards
- Provide technical leadership, mentor and guide the change owners and Project Leads within its product family in order to get tasks accomplished according to plans, milestones and business needs
- Review and approve Design Control documentation for projects in development and sustaining activities.
- Responsible and accountable for the design history files of a given product family
- 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 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's questions
- Provide technical leadership for products/process/cost improvements related to life cycle management projects
- Provide resource estimation and forecast
- Ensure good internal and cross-functional communication at a global front and regular status update of projects
- Master's in chemistry or M. Pharm. with at least 14 years of relevant experience or Ph.D. in relevant sciences discipline with at least 7 years of relevant experience.
- 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
- Prior experience of product design owner (PDO) role for drug/pharmaceutical products and medical devices
- 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.
Research Scientist I - Bengaluru, India - Baxter
Description
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Job Summary
• Job Title –Research Scientist I
• Location – Whitefield, Bangalore
• Shift – General
Job Responsibilities:
Qualifications and Skills