Research Scientist - Renal Product Organisation
DescriptionOur employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters.
Do you want to know why it is so wonderful to work for Baxter? Go to https://www.youtube.com/watch?v=OY89yj_zSIo
As Research Scientist in the renal sustaining product organisation, you will be responsible for life cycle product management
More specifically, you will:
- Act as Technical Lead and Expert for sustaining projects and lifecycle management activities related to Renal Chronic Products
- Support Renal Solutions Formulation Development for New Product Development (NPD) and On-Market Renal Solution products for Sustaining Product Operations (SPO)
- Organize, plan and execute product changes in compliance with international regulations and quality standards; coordinate and set up cross-functional team meeting to ensure change execution, problem-solving and decision making
- Provide technical assessment for product changes related to labeling, raw material, manufacturing process, regulatory requirement, design change and quality improvement
- Independently plan, execute, and manage project(s) that both span multiple disciplines with team, cross functions and regions. Applying a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise.
- Provides assistance and interpretation of project results to team members and other business unit personnel.
- Serve as the interface between R&D, quality, and regulatory to update and harmonize product specifications to global regulatory and quality standards.
- Efficiently execute programs in such a way to reduce cycle-time while meeting all regulatory and quality requirements under management direction. Develop budgets and schedules of small to medium scope.
- Develop new or improved techniques and procedures around specific tasks; write and implement SOP's. Develop research outlines for large scientific projects. Apply state-of-the-art techniques in the area of expertise to develop new or improved products.
- Maintain current knowledge of relevant Quality System Regulations, therapeutical PDP and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
- In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
QualificationsWho You are
- Bachelor's degree in a scientific discipline ( Chemistry/Biology/Engineering) with at least 10 years, MS or PHD with at least 5-7 years of relevant experience.
- Background in problem solving in solutions/drug development and the utilization of analytical instrumentation.
- Design and implementation of technical studies.
- Technical writing proficiency/authoring internal reports and scientific papers.
- Giving presentations within the business/technical community.
- Interpretation of results from HPLC, IR, NMR, LC/MS, GC/MS, TGA/DSC, GC.
- Demonstrated ability to lead global technical projects through successful outcomes on projects.
- 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
- Working knowledge of international/regional/national regulations and standards
- Experience in management of technical projects
- Ability to work independently and propose options to solve issue
- Ability to communicate effectively with internal and external customers
- Ability to break down technical processes and effectively delegate to junior team members
- Demonstrates flexibility and ability to shift gears between projects comfortably
- Fluency in English
It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you.
If you want to learn more about career opportunities go to http://www.baxter.com/careers.page
Who we are
Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide. You’ll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products.
Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations for the world.
Our 50,000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care.
Our inclusive culture and a diverse workforce drives innovation, creates trusted partnerships with customers, suppliers, and community partners, and contributes to the success and sustainability of our business.
Every day at Baxter is a chance to save and sustain lives
Equal Opportunity Employer Discrimination: Baxter is an equal opportunity employer. Baxter 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.
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