Associate Scientist II, R&D, Complex Product Development Job at Baxter (Ahmedabad)

Job Description

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. 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.

Job Responsibility

To plan and perform sample analysis (analytical method development, validation, technology transfer, etc) activity following GxP & GDP practices for regulatory submissions for complex injectables like peptides, iron formulations, etc
Assist in regulatory query responses for Complex Products
To perform testing of Complex Injectable samples, including, API, development, validation, stability, bulk hold, RLD, PDR and any other samples as required, according to appropriate method of analysis
To be competent in analytical problem-solving, focus on innovation, process improvement and operational excellence
To keep track of all activities related to product analysis, ensure completion in the stipulated time, and inform the Sub-department manager if any deviation or issues observed
Preparation and review of analytical reports, SOPs and MOAs by referring to GQP & current pharmacopoeia as per requirement
To carry out all testing and data recording according to the approved SOPs following GDP & ALCOA++ principles and current pharmacopoeia
To use appropriate reference and working standards for analysis and maintain their records
To complete all training as per the quality matrix targets
To perform or review the calibration records of instruments as per approved SOPs
To manage preventive & breakdown maintenance, perform risk assessment and suggest immediate corrective actions as and when required
To report and investigate any failure / abnormal observation / OOT / OOS / deviation / Non-Compliance to sub-department manager and seeking for the solutions
To list all resources required for the study, keep track of routine requirements, ensure timely procurement of the same, and verify the materials received for analysis from suppliers
To review stability program for finished product, monthly data logger reports and qualification documents for stability chambers
To ensure timely review of DMF of API vendors, manage API and Excipient Vendor Approval process of New Product and existing products
To review the status of daily work of the team and report to the Manager

Requirements

Master's in science with 8 to 12 years of Experience
Good experience in the execution of analytical method development, validation and technology transfer and routine analysis for peptides and iron colloidal drug products for regulatory submission
Competency with method relevant to iron DS/DP analysis, including particle size distribution by gel filtration chromatography, light scattering/diffraction/obscuration methods, assay of various iron forms, e.g. ferrous, ferric, labile iron, chelation assays, reduction potential and kinetics, etc, is strongly desired
Basic Knowledge and execution of Chemical Analysis using techniques relevant to complex injectables
Knowledge of pharmacopoeia, ICH Guidelines
Execution of Operational and Calibration of Instrument on periodic basis
Trouble shooting of various problems obtain during the during analysis
Knowledge of Transfer of Technology
Knowledge of Good Laboratory Practice and Good Documentation Practices
Communication skills
Presentation skills
Analytical skills
Lateral coordination
Positive Attitude
Policy compliance
Documentation Skills
Problem Solving

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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Associate Scientist II, R&D, Complex Product Development

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