Designation/Position- Research Scientist I
Baxter International, Health care company, Bangalore, India offers position of research scientist I position.Candidate having bachelor’s degree in a scientific discipline with 10 years experience, MS with at least 5-7 years, or PhD with 0-2 years in relevant discipline can apply
About- 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. 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.
Baxter’s employees are united in a mission to save and sustain lives. Company passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Location- Baxter International, Health care company, Bangalore, India
Research/Job Area- Research and Development- Biocompatibility
- The position requires relevant technical knowledge in biocompatibility and general understanding of material physical and chemical properties.
2. Ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ISO10993 series, regional compendia.
3. Good oral and written communication in English.
4. Experience in working in global cross-functional teams and project management.
5. Critical thinker with intellectual self-assurance and courage. Independent problem solver who can use a methodical approach to develop solutions and make recommendations.
6. Ability to make decisions when provided with limited information.
7. Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met
8. Excellent attention to detail.
9. Software knowledge of Siemens Teamcenter Unified, Microsoft Office, and TrackWise recommended
Education and/or Experience– Bachelor’s degree in a scientific discipline with 10 years experience, MS with at least 5-7 years, or PhD with 0-2 years in relevant discipline required.
Job/Position Description- Develop testing strategies and manage biocompatibility testing to qualify materials used in Baxter’s portfolio (Devices, Disposables, and Container Closure System) according to global guidelines. Mentor junior staff in biocompatibility qualification. Understand and interpret regional compendia and ISO 10993 guidelines. Develop biocompatibility content for 510K submissions, CE mark, and DHF files.
Essential Duties and Responsibilities:
- Effectively coach and mentor junior team members
- Manage projects to coordinate biological safety testing for Baxter’s product portfolio.
- Develop biocompatibility testing strategies to qualify materials used according to global guidelines. Ensure compliance with regulatory guidelines.
- Develop preclinical regulatory summaries for DHF files, USA FDA 510 K submissions, and CE Mark.
- Utilize Siemens Teamcenter Unified global material management system (GMMS) for biocompatibility testing and product development and registration support.
- Develop project schedules; provide estimates and timelines to meet project milestones.
- Attend Project Review and Core team meetings
- Implement the use of ISO10993-1, regional pharmacopeia, 21 CFR Part 58 Good Laboratory Practices for Non-Clinical Laboratory Studies, and/or other regulatory guidance documents to qualify Baxter products.
- Perform biocompatibility assessments in Trackwise 8 and work with cross functional team members (engineering, extractables and leachables, etc.) in order to determine a comprehensive testing strategy.
How to Apply- Eligible and interested candidate can apply online.