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Associate Scientist II, R&D, Complex Product Development

https://www.baxter.com/ Logo

Baxter

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Location:
India , Ahmedabad

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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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.

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
  • 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
  • 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
  • To plan work schedule as per requirement by respective department
  • To liaise with customers, staff, and suppliers
  • To respond to the query in the stipulated timeline
  • To ensure documentation is in line with analysis
  • To monitor compilation required data for Management Information System and provide to Sub-department Manager
  • To perform the documentation and QMS related activity using applications software like TCU, Trackwise, etc
  • To communicate any failure, deviation or abnormal notification or non-compliance in results to Sub- department Manager
  • To communicate project related issues to Sub-department Manager and follow the action plan
  • To keep status of daily work and report to Sub-department Manager on daily basis

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

Additional Information:

Job Posted:
May 11, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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