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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. Summary: 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, including proteins & peptides, oligonucleotides, iron formulations, carbohydrates & other biomolecular APIs and various impurities in lyophilized, liquid, emulsions & other formulations for regulatory submission following GLP norms
To manage outsourced studies at CROs, academic institutes & other external facilities, from study design, execution, analysis and report preparation
To demonstrate subject matter expertise and help overcome technical challenges in product development, by liaising with formulation and other cross-functional teams as a Subject Matter Expertise (SME)
To understand the project with guidance of Sub-department Manager and follow their instructions
To provide necessary assistance for various procurement activities, review quotations, engage suppliers to procure required goods & services in a timebound manner
To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed
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 and current pharmacopoeia
To verify the shelf life of the chemical or reagent before performing analysis of the material or product
To follow Good Documentation Practices & Good Laboratory Practices, maintain lab notebooks & other records appropriately
To investigate if any deviation / abnormalities are observed and report to Sub-department Manager
To check the trend of results before reporting the results
To keep the status of daily work and report to Sub-department Manager on daily basis
To undertake operation, calibration, preventive and breakdown maintenance of the instruments as per approved standard operating procedure
To list all resources required for the study and keep track of routine requirements and ensure timely procurement of the same, verify the materials received for analysis from supplier as per given requirement
To complete training as per the quality matrix targets
To prepare and update the SOPs
To prepare method development and verification report
To perform the work as allocated by Sub-department Manager
To liaise with customers, staff and suppliers
To write / fill the record in legible writing
To keep the documentation online with analysis
To compile required data for Management Information System and provide to Sub-department Manager
To communicate about any failure or abnormal notification or non-compliance in results to Sub-department Manager and help resolve them in a timely manner
To communicate project related issues to Sub-department Manager and follow the action plan
Requirements:
Masters (Pharmacy, or equivalent discipline) with 6 to 10 years of experience, or, PhD (biophysics, biochemistry or equivalent discipline) with 0 to 5 years of experience with spectroscopic and biophysical methods, including CD, FTIR, fluorescence spectroscopy
Competency in the acquisition, processing and data analysis by CD, FTIR, and fluorescence spectroscopy for analysis of proteins and peptides for regulatory submissions is mandatory
Expertise in computational chemistry, molecular modeling and statistical methods are beneficial attributes
Basic understanding of working principles of liquid chromatographic methods, dynamic light scattering, AF4-MALS, SV-AUC, & related orthogonal methods to assess protein higher order structures
Proficiency in literature search through publication and patent databases, repositories (e.g. Pubmed), scientific webinars by regulatory agencies, etc, to remain updated on advanced characterization methods and recent scientific developments
Knowledge of pharmacopoeia, ICH Guidelines and means to implement them for product development
Experience in the operation, calibration and preventive maintenance of NMR and other instruments to ensure continued usage
Trouble shooting of various problems obtain during the product development
Knowledge of good laboratory practices and good documentation practices