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Research Associate II, R&D - F&D

Req #: JR - 120027 Location: Ahmedabad, Gujarat, India Job Category: Research and Development Date posted: 02/28/2024

Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Courage
  • Action Oriented
  • Collaborates
  • Cultivates Innovation
  • Manages Ambiguity
  • Drives Results

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Research Associate II, R&D - F&D

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—where your purpose accelerates our mission.

    • Execution of development trials
    • Compilation & evaluation of the development & stability data
    • Ensuring development trails to be performed as per QBD approach.
    • Prepare the technical documents e.g. MFR, PDR, PDLM documents, Protocols & Reports.
    • Provide required information for meetings with CFT's (Analytical, Regulatory, PSM, Quality, manufacturing, CMO, Project management) for on time project delivery.
    • Provide required information for meetings with CMO’s CRO’s & contract Labs for on time project delivery.
    • Support for successful Technology transfer of Drug products.
    • Support in execution of stability batches in Baxter sites & CMO.
    • Support for Process validation and commercial batches.
    • Technology transfer documents review of Products developed by CRO as per regulatory requirement.
    • To review engineering batch & stability batch documents.
    • Collection of the Stability batch data and review for trending.
    • Review of Artworks.
    • API, Raw material, packing material & Product specifications preparation & review of developmental products & commercial products. Raw material and packing material specifications for the regulatory filing, CMO & for manufacturing plant.
    • Perform the required activities for remediation projects to fulfill the Regulatorycommitments/OOS/ProjectCCN's/CAPA/Product nature and criticality.
    • Perform the required activities to fulfil the regulatory submission & query requirements.
    • Prepare the reports to be provided for regulatory response
    • Self-Knowledge enhancement.
    • To handle trouble shooting during exhibit and commercial batches with an ability to investigate any Out of Specification (OOS) or Out of Trend (OOT) results.
    • To interact with the plant team and impart new product introduction prior to start of production.
    • To support External and Internal regulatory audits with respect to Manufacturing Process.
    • To support for market complaint related activities.
    • To possess and be updated on product submission and knowledge in regulatory market, current guidelines i.e. ICH, US-FDA, MHRA, EMEA etc.
    • To identify & make available the necessary required resources or infrastructure or instruments to carry-out the day-to-day functions. And ensure entire documentation related to formulation development & execution of batch.
    • To assist Manager & Department Head in investigation for complaints and deviations. To analyze investigation done by Executive, to suggest any further actions required, to conclude root cause and to seek approval of Corrective and Preventive Action (CAPA) from Department Head.
    • To prepare change control and ensure timely closure of the same.
    • Support & coordination with CMO's for successful technology transfer
    • Ensuring Lab equipment, instruments, documentation & Warehouse compliance
    • Preparation of SOP's
    • Documenting experiments in ELN.
    • Identification & request of NewEquipment's/Instrumentsfor projects in upcoming portfolio & continuous improvement of Development Lab.
    • To adopt & follow the Global Quality procedures.
    • To identify the safety hazards & perform the HIRA in coordinates with EHS safety practices at place.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

120027

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.

Reagan

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.

Karthik

Meet Amitha, Research Associate in India

Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter

Amitha

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Reagan

Meet Reagan, Senior Research Scientist in the United States

For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.

Karthik

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.

Amitha

Meet Amitha, Research Associate in India

Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter

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