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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. ... The person will be responsible for the execution of advanced characterization studies (including Method Development, Method Qualification, Sameness Study and Routine Analysis of complex injectables) performed at Complex Product Development, Research & Development, Baxter Ahmedabad. The Person is also responsible to provide an analytical support to Baxter Global, and Baxter’s Contract manufacturing sites.
Job Responsibility:
To perform advanced characterization of complex injectable drugs
To manage outsourced studies at CROs, academic institutes & other external facilities
To demonstrate subject matter expertise and help overcome technical challenges in product development
To provide necessary assistance for various procurement activities
To complete the planned work in the stipulated time frame
To keep track of each activity related to product analysis and development activities
To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle
To verify the shelf life of the chemical or reagent before performing analysis
To follow Good Documentation Practices & Good Laboratory Practices
To investigate if any deviation / abnormalities are observed
To check the trend of results before reporting
To keep the status of daily work and report to Sub-department Manager
To undertake operation, calibration, preventive and breakdown maintenance of the instruments
To list all resources required for the study
To complete training as per the quality matrix targets
To prepare and update the SOPs
To liaise with customers, staff and suppliers
To compile required data for Management Information System
To communicate about any failure or abnormal notification or non-compliance in results
To communicate project related issues to Sub-department Manager
Requirements:
Masters (Pharmacy, or equivalent discipline) with 6 to 10 years of experience
PhD (biophysics, biochemistry or equivalent discipline) with 0 to 5 years of experience
Competency in the acquisition, processing and data analysis by SEC-UV-MALS and light scattering/diffraction/obscuration techniques for analysis of peptides and iron colloidal products for regulatory submissions is mandatory
Basic understanding of working principles of biophysical & spectroscopic methods
Knowledge of pharmacopoeia, ICH Guidelines
Experience in the operation, calibration and preventive maintenance of NMR and other instruments
Knowledge of good laboratory practices and good documentation practices
Communication skills
Presentation skills
Analytical skills
Lateral coordination
Positive Attitude
Policy compliance
Documentation Skills
Nice to have:
Expertise in computational chemistry, molecular modeling and statistical methods