Research Assoc Iii R&d Charact.

Year    Ahmadabad, Gujarat, India

Job Description

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This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You\'ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter\'s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives\xe2\x80\x94where your purpose accelerates our mission. Essential Duties and Responsibilities: Summary: Support the Extractables and Leachables scientific excellence of the Ahmedabad R&D. As a senior member of this team, lead the structure elucidation efforts of unknown leachable using of state-of-the-art technology (LC-MS, GC-MS, GC, UV, LC, IC, ICP-MS, ICP-OES) and to solve complex analytical problems & investigations, including Structure Elucidation. Ensure technical capabilities and expertise are aligned with business needs to sustain products, support development of new products, contribute to investigations, and drive specific innovation initiatives to position the organization for the future. Collaborate with Team Lead and global subject matter experts to meet the needs of partners across Baxter\xe2\x80\x99s Global Business Units. Ensure Quality culture and compliance is embedded in the team and lab. Build a professional network within the business unit, across units and outside of Baxter. Essential Duties and Responsibilities:
  • The Research Associate III is responsible for contributing to all phases of Extractable & Leachable and related studies carried out IH and at CROs. This would include study design as sample preparation, analysis, and data interpretation.
  • Independently or with support of sub department manager, author and contribute to the experimental protocols, process and interpret data, author technical reports in English.
  • Ensure technical output of the team is of the highest quality, scientifically sound and appropriately addresses the business need.
  • Lead the structure elucidation efforts of unknown leachables to convert them to known using analytical techniques and theoretical concepts within shortest time period possible to avoid business impact.
  • Create, maintain and update a library of potential leachables and extractables of the container closure systems that will be used or already used for NPDs.
  • Train and develop future pipeline for the structural elucidation skill.
  • Help Functional head in identifying the required infrastructure to strengthen the structure elucidation capabilities in-house.
  • Support in writing regulatory section write ups and toxicological risk assessments in justifying the presence of unknowns without posing harm to patients.
  • Ensure compliance in all research, data collection and reporting activities.
  • Supervise and direct the lab work for junior level executives.
  • Maintain current knowledge of relevant Quality System Regulations 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.
  • Support the build out of the R&D- E&L laboratory.
  • Develop and enhance technical capability through training and on job experience.
  • Ensure laboratory is equipped with instrumentation that is qualified to appropriate standards, maintained in a functional state and aligns with the business needs.
  • Key contributor during experimental study designs, execution and review/approval at IH & CROs study.
  • Competent in interpreting complex analytical data and presenting in a form that is suitable for a wide-ranging audience.
  • Collaborate with a multidisciplinary team of subject matter experts to generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.
  • Create innovative products/processes/methods through novel combinations of expertise within the organization.
  • Contribute to the long-term scientific strategy of the department.
Influence the regional external regulatory environment in the areas of Extractables & Leachables, Elemental Impurities, and Structure Elucidation. Write technical reports and documenting development work. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information. Recruitment Fraud Notice

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Job Detail

  • Job Id
    JD3046110
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Ahmadabad, Gujarat, India
  • Education
    Not mentioned
  • Experience
    Year