Analytical Scientist - Microbiology

Job Summary

• You will be responsible to organize the microbiology laboratory for safety and good laboratory compliances. Report discrepancies in procedures/ products/ materials/people practices/ systemic issues/ any other abnormalities to microbiology team lead.
• You will be responsible to initiate and implement updated procedures as per lab requirement. Online documentation will be required.
• You will be responsible for planning the daily activities for microbiology testing and ensure availability of worksheets for all the microbiology samples and tracking timely planning and testing.
• You will be responsible to ensure that the Standard Operating Procedures /Standard Test Procedures are replaced in their designated place after completion of the analysis.
• You will be responsible for timely submission of daily status report to team lead.
• You will be responsible to execute the periodical environmental monitoring of the aseptic area as per procedures.
• You will be responsible to ensure the Good Laboratory Practice (GLP) compliance for all instruments/Equipment’s located at Microbiology lab.
• You will be responsible for analysis of finish product, raw material and excipient, Microbial Limit Test method developments and method validations.
• You will be responsible for Antimicrobial Efficacy Test method development and method validation and batch analysis.
• You will be responsible for various validation methods like Sterility method validation and Bio-burden method validation for batch analysis by open method and closed method.
• You will be responsible for Identification of microorganism through Vitek-2 compact.
• You will be responsible for Bacterial endotoxin test method validation and batch analysis by Gel clot method and kinetic method Chromogenic and Chromogenic and Turbid metric method.
• You will be responsible for Microbial kill rate study as per the Food and Drug Administration (FDA) requirements and Microbial potency assay method development and method validation study.
• You will be responsible for Media preparation and reconciliation, culture handling and culture maintains and stock maintenance.
• You will be responsible for Handling of steam sterilizer, Laminar Airflow (LAF), Biological Safety Cabinet (BSC) and Isolator.
• You will be responsible for Environmental monitoring in aseptic areas and purified water, Water for injection (WFI) analysis and trends preparation. Also adhere to the safety and quality aspects.
• You will be responsible for Operation of Laboratory Information Management System (LIMS) software, Operation of International Caries Detection and Assessment System (ICDAS) and Allyone software. 

Educational qualification:

• Experience in Medical Laboratory technology (MLT) method developments and method validations and batch analysis.
• Experience in Antimicrobial test method development and validation and batch analysis.
• Experience in Sterility method validation and batch analysis by open method and closed method.
• Experience in Bio-burden method validation and batch analysis for in process samples.
• Knowledge on Microbial kill rate study as per the Food and Drug Administration (FDA) requirements.
• Knowledge on Microbial potency assay method development and method validation study.
• Experience in Bacterial endotoxin test method validation and batch analysis by Gel clot method and kinetic method Chromogenic and Chromogenic and Turbidity metric method.
• Expertise on Microbiology Lab related Instrument/Equipment calibration (Balance, pH meter).
• Experience in Preparation of Method validation protocol and report.
• Experience in Preparation of Standard Operating Procedures /Standard Test Procedures.
• Knowledge on aseptic process and behaviour.
• Knowledge on Deviation, Incidents with investigation and associated CAPA.
• Experience in handling of regulatory audit.

Behavioral Skills

• Excellent communication and interpersonal skills.
• Ability to work with cross functional teams.
• Strong analytical and problem-solving abilities. 

About the Department

Integrated Product Development Organisation

Benefits Offered