Research Associate III

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Job title: Research Associate III

Company: Baxter

Job description: 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.

About Baxter:

Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.

This position is responsible for the development, validation and transfer of analytical methods, preparation of analytical gap assessments as well as support of analytical/stability testing/design experiment with Baxter external partners. The successful candidate would apply sound chemistry to engage in cross-functional Analytical Leadership activities and problem solving and would apply appropriate analytical methodologies to the development of new products and the support of existing products.

Job Title – Research Associate III
Location – Whitefield, Bangalore
Shift – General

Job Responsibilities:

  • Represent R&D – Analytical as member of project teams. Actively participate in success of project team goals.
  • Develop analytical strategies and plans for new product development and sustaining product projects.
  • Leads the analytical transfer plan globally to manufacturing plants, CRO and other RD centers.
  • Identifies and plans for all analytical resources needs, capabilities and capacity required for the execution of the analytical strategy plan.
  • Act as a study director for these designs and execute method validation and transfer studies.
  • Perform analytical gap assessment of in-use analytical methods and provide strategic action plan to remediate.
  • Prepare and review analytical documents (Validation/Transfer protocols/reports, special reports).
  • Review analytical raw data to ensure compliance with analytical methods, global and local procedures.
  • Collaborate with global stakeholders and Baxter external partners to ensure successful execution of analytical testing and study designs.
  • Contribute to technical feasibility analysis of complex research and design concepts.
  • Contribute to Analytical sections intended for submission to regulatory authorities and responses to authorities.
  • Prepare investigation plan for validation/transfer failure, OOS, OOT and Incidents. Leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles.
  • Demonstrate the ability to identify risks, issues, and opportunities.
  • Collaborate with other functions such as project management, regulatory, formulation, manufacturing, external supplier and quality control in project teams.
  • Lead the analytical problem-solving efforts to meet urgent business needs.
  • Maintain knowledge of relevant QSR and other regulatory requirements related to R&D (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 current regulatory guidelines, cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
  • Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
  • Maintain focus on meeting both external and internal customer expectations.
  • Having critical mind and scientific curiosity. Ability to manage different priorities, deadlines and conflicts.
  • Good communication skills and having multi-tasking ability.
  • Must possess strong verbal and technical writing skills.
  • Willingness to work across multiple time zones.
  • Coach and mentor junior members working in analytical methods development, validation and gap assessment.

Qualification and Skills:

  • Bachelor’s degree in relevant scientific discipline with 10+ years of relevant experience or Master’s degree with 8+ years of relevant experience or PhD with 5+ years of relevant experience.
  • Experience with analytical method development, validation and transfer.
  • A good understanding of ICH, Ph. Eur, USP guidelines and cGxP practice.
  • Familiarity and hands-on experience with HPLC, GC, UV, AAS, FES, Empower and other analytical instruments and software.
  • Ability to learn quickly and to solve problems in a timely manner using analytical chemistry skills.
  • Possess relevant writing and computer skills.
  • Ability to organize, assess and communicate complex information that engages the audience.
  • Ability to make decisions when provided with limited information and to make routine decisions independently.
  • Ability to design experiments and draw meaningful conclusions from lab data.
  • Experience in working in global cross-functional teams and project management is a plus
  • Quality oriented.
  • Ability to adapt to changes and to work in a team environment.
  • Ability to identify and solve technical issues.

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.

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Expected salary:

Location: Bangalore, Karnataka

Job date: Thu, 14 Jul 2022 00:24:27 GMT

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