Research Associate Ii

1 week ago

Bengaluru, India BAXTER Full time

**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.

Job Title - Research Associate II
Location - Whitefield, Bangalore
Shift - General

**Responsibilities**:

- Represent Global R&D-Analytical on project teams as a key part of the project teams’ goals and success.
- Develop analytical plans for new product development(NPD) and sustaining product projects(SPO)
- Represent R&D - Analytical as member of project teams. Actively participate in success of project team goals
- Identifies and plans for all analytical resources needs, capabilities and capacity required for the execution of the analytical strategy plan
- Leads the analytical transfer plan globally to manufacturing plants, CRO and other RD centers
- Without assistance, make sound technical recommendations regarding analytical method validation, transfer and testing that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
- Employ appropriate techniques/methods to successfully and independently execute routine analytical activities within negotiated deadlines. Identify alternative methods and technologies for improving existing or new products/processes
- 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
- Contribute to technical feasibility analysis of complex research and design concepts, execute studies such as development, validation and transfer of analytical methods as on when required. Support analytical problem solving efforts to meet urgent business needs.
- Prepare and review analytical documents (Validation/Transfer/Development protocols/reports, special reports) in compliance with analytical methods, global and local procedures.
- Contribute to Analytical sections intended for submission to regulatory authorities and responses to authorities.
- Demonstrate the ability to identify risks, issues, and opportunities.
- Lead the analytical problem-solving efforts to meet urgent business needs and contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
- Prepare investigation plan for validation/transfer failure, OOS, deviations 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 global functions, such as project management, regulatory, formulation, manufacturing, external supplier, external partners and quality control in project teams to ensure successful execution of analytical testing and study designs.
- Maintain knowledge of relevant QSR and safety requirements while building knowledge of 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.
- Coach and mentor junior members working in analytical activities not limited to methods development, validation, transfer and gap assessment.
- Co-ordinate with technical lead/study director to execute a series of study de

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