Research Scientist, I Research & Development
Baxter · Ahmedabad, Gujarat, India
Free account: apply link, HR contact and an AI-written cold email
Baxter · Ahmedabad, Gujarat, India
Free account: apply link, HR contact and an AI-written cold email
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Role at Baxter: As a member of the Global Pharmaceutical R&D (GPRD) Complex Product Development team, you will lead and execute analytical activities supporting the development of complex injectable products, including peptides and iron-based formulations. You will be responsible for analytical method development, validation, technology transfer, stability studies, and regulatory support while ensuring compliance with GxP (Good “x” Practice), GDP (Good Documentation Practices) and global quality standards. This role is critical in driving product development, regulatory submissions, and lifecycle management across Baxter's global portfolio. What You'll Be Doing: Execute analytical method development, pre-validation, validation, and technology transfer activities for complex injectable drug products. Perform testing and characterization of APIs, drug products, stability samples, development batches, validation batches, and reference listed drugs (RLDs). Support regulatory submissions by generating analytical data and responding to regulatory queries. Develop and review analytical reports, SOPs (Standard Operating Procedures), methods of analysis (MOAs), protocols, and laboratory documentation. Conduct analytical investigations related to OOS, OOT, deviations, non-conformances, and laboratory abnormalities. Perform routine operation, calibration review, qualification support, and troubleshooting of analytical instruments. Execute and interpret complex analytical techniques relevant to peptides and iron colloidal drug products. Support preventive maintenance, risk assessments, and corrective actions for laboratory equipment and systems. Ensure accurate data recording in ELN and compliance with GxP, GDP, ALCOA++, ICH guidelines, and pharmacopoeial requirements. Review stability programs, qualification documents, data logger reports, and vendor documentation. Manage API and excipient vendor approval activities and review Drug Master Files (DMFs). Coordinate with cross-functional teams, contract manufacturing sites, suppliers, and global stakeholders to meet project timelines. What You'll Bring:
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