Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre 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.
Post : Research Scientist I (Hybrid)
Job Description
• 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
Candidate Profile
• 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.
Additional Information
Experience : 5+ year
Qualification : Master’s in Chemistry or M.Pharm
Location : Bengaluru, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research and Development
End Date : 20th May 2024
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