Research Associate III
5 months ago
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 Us: Baxter's Mission
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.
Your Role at Baxter
This is where your work saves lives
The research we do and the products we develop improve outcomes for patients around the world. As a Research Associate at Baxter, your work contributes directly to making a significant impact on others. It's exciting work—and you're not on your own. Our teams collaborate cross-functionally and lead by influence.
Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.
What you'll be doing
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 that are more routine than not.
Provide some analysis/redesign of key experimental procedures.
Employ appropriate techniques/methods to successfully and independently complete routine assignments related to stability study design and development within agreed timelines.
Identify alternative methods and technologies for improving existing or new products/processes.
Maintain relevant QSRs and other regulatory requirements, such as the stability related ICH guidelines, for R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
Recommend appropriate study designs, techniques, and processes for a specified sequence of tasks where needed, including the use of LIMS systems for electronic stability protocols.
Providing technical rationale for expiration dating and label storage statement recommendations, preparing regulatory submissions, responding to regulatory communications.
Ensuring 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/strategies, which accomplish business objectives such as quality and cycle time.
Displays a solid understanding of theories/practices applied by other fields outside the primary area of expertise.
In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, can be able to provide advice and/or is an active participant in the generation, review, adoption, and interpretation of such regulations.
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.
Ensuring compliance related results are completed on schedule and per plan.
Collaboration with cross functional teams such as QA, M&Q, Regulatory, Quality control, and all the 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 & tidy.
To follow all the 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 SOP's.
Expertise to develop new and improved products.
Able to handle the NCR/sNCR and Change controls.
Participate and Drive harmonization efforts across Baxter sites for stability practices
What you'll bring
Educational Qualification- Graduate / Postgraduate in Pharmacy from a reputed institution.
Experience Range (desirable) – 6-12 years of experience in IN-PROCESS and R&D STABILITY analysis.
Proven experience in stability protocol writing and responding to regulatory queries.
Experienced in managing OOS investigations, deviations, change controls & CAPA’s as per GMP procedures.
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