Research Assoc I, R&D - Complex Product Development (Characterization)

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The person will be responsible to undertake computational and experimental studies on complex injectable drug products performed at Complex Product Development, Research & Development, Baxter Ahmedabad. The Person is also responsible to provide an analytical support to Baxter Global, and other R&D sites as and when required Essential Duties and Responsibilities: Quality: ·       To perform advanced characterization of complex injectable drugs , including proteins & peptides , oligonucleotides, iron formulations, carbohydrates & other biomolecules in lyophilized, liquid, emulsions & other formulations by computational methods 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. Traveling to external facilities, as and when required, is a mandatory requirement for this position. ·       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. Data recording in ELN and sign off must be completed on time. ·       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 mainte the instruments as per approved standard operating procedure. To report on the conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager. ·       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. Administrative: ·       To perform the work as allocated by Sub-department