Research Associate III

4 weeks ago

Ahmedabad, Gujarat, India Baxter Full time

About Us: Baxter's Mission

Baxter is a leading global medical technology company that creates innovative products and therapies that improve patient outcomes and save lives. Our mission is to drive healthcare forward and make a meaningful difference in the lives of patients around the world.

Your Role at Baxter

As a Research Associate III at Baxter, you will play a critical role in the development of new medical products and therapies. Your primary responsibility will be to design and execute stability studies to ensure the quality and safety of our products.

Key Responsibilities

  • Develop stability study designs for new product development and sustaining product projects.
  • Make sound technical recommendations regarding stability study designs for new product development and sustaining product projects.
  • Provide analysis and redesign of key experimental procedures.
  • Employ appropriate techniques and methods to successfully complete routine assignments related to stability study design and development.
  • Identify alternative methods and technologies for improving existing or new products and processes.
  • Maintain relevant QSRs and other regulatory requirements for R&D to ensure compliance in all research, data collection, and reporting activities.
  • Recommend appropriate study designs, techniques, and processes for a specified sequence of tasks.
  • Provide technical rationale for expiration dating and label storage statement recommendations, prepare regulatory submissions, and respond to regulatory communications.
  • Ensure compliance-related deliveries are completed as per plan and decided timelines.
  • Independently plan and complete a series of stability study designs and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated timelines.
  • Play a lead role in the evaluation, selection, and adaptation of various techniques and strategies that accomplish business objectives such as quality and cycle time.
  • Display a solid understanding of theories and practices applied by other fields outside the primary area of expertise.
  • Maintain focus on meeting both external and internal customer expectations.
  • Contribute to technical feasibility analysis of complex research and design concepts.
  • Evaluate results relative to product requirements, definitions, and/or program goals.
  • Ensure compliance-related results are completed on schedule and per plan.
  • Collaborate with cross-functional teams such as QA, M&Q, Regulatory, Quality Control, and all projects.
  • Coordinate with team members to progress the projects and internal activities in a right direction to achieve the organizational requirement.
  • Maintain audit readiness and keep lab premises clean and tidy.
  • Follow all relevant cGxP and related regulations.
  • Own the analytical problem-solving efforts to meet urgent business needs.
  • Focus on innovation, process improvement, and/or operational excellence initiatives.
  • Independently plan, execute, and manage projects/programs that both span multiple fields and use established methods, techniques, or approaches.
  • Implement new or improved techniques and procedures around specific tasks; write and implement SOPs.
  • Expertise to develop new and improved products.
  • Able to handle NCR/sNCR and Change controls.
  • Participate and drive harmonization efforts across Baxter sites for stability practices.

What You'll Bring

We are looking for a highly skilled and experienced Research Associate III to join our team. The ideal candidate will have a strong background in pharmaceutical research and development, with a focus on stability study design and execution. A graduate or postgraduate degree in pharmacy from a reputable institution is required, and 6-12 years of experience in IN-PROCESS and R&D STABILITY analysis is desirable.

The successful candidate will have a proven track record of experience in stability protocol writing and responding to regulatory queries, as well as managing OOS investigations, deviations, change controls, and CAPAs as per GMP procedures.

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